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Name
of Manufacturer |
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Physical
Address |
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Drug Manufacturing license No. and Validity (Date of application for DML renewal) |
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Contact
Address |
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Date
of inspection |
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Purpose
of inspection |
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Name
of inspector (s) |
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Name
of Firm’s Representative (s) accompanying during an inspection |
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General Information about the Unit:
Detail of manufacturing section(s)
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Pharmacological Category(ies) |
Dosage Form |
Total Number of Registered products |
Remarks (if any) |
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Sr. No. |
Contents |
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1. |
Quality
Assurance |
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2. |
Premises |
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3. |
Personnel |
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4. |
Validation |
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5. |
Documentation
/ Records |
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6. |
Vendor
Qualification |
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7. |
Change
Control Program |
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8. |
Sample |
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9. |
Stability
Studies |
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10. |
Drug
Recall |
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11. |
Annual
Product Review |
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12. |
Audits |
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13. |
Quality
Control Departments |
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14. |
Manufacturing
Area |
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14.1 |
Equipment |
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14.1.1 |
Equipment
Calibration |
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14.1.2 |
Material
/ Component |
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14.2 |
Raw
Material |
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14.3 |
Purified
and Water for Injection Systems |
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14.4 |
Depack
/ Preparation component room |
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14.5 |
Sterilizer
/ Oven Loading Room |
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14.6 |
Equipment
Airlock |
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14.7 |
Washroom
/ Grown change room |
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14.8 |
Manufacturing
(Sterile Product) |
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14.9 |
Aspectic
Batching Area |
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14.11 |
Filling
room |
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14.14 |
Terminal
Sterilization |
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14.15 |
Packaging |
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14.16 |
Manufacturing
(Oral dosages) |
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14.17 |
Packaging |
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15. |
Reprocessing |
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16. |
Finished
Product Control |
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17. |
Warehouse
/ Distribution |
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18. |
Environment,
Health & Safety |
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Sr. No. |
Criteria |
Yes |
No |
Not Applicable |
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(To be filled by Auditee) |
To be filled by
Auditor |
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1.0 |
QUALITY ASSURANCE |
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1.1 |
Does the company have a mission statement and a quality policy? |
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1.2 |
Is the company ISO certified? |
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1.3 |
Was the company previously audited (GMP
audit)? |
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1.4 |
Are pharmaceutical products designed and developed
according to the requirement of GMP &
other associated codes such as good
laboratory practice (GLP) and good clinical practice (GCP)? |
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1.5 |
Are production and control operations clearly
specified in a written form and GMP requirements are adopted? |
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1.6 |
Are managerial responsibilities clearly specified
in job descriptions? |
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1.7 |
Are all necessary controls on starting materials,
intermediate products and other in-process controls, calibrations and
validation carried out? |
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1.8 |
Are finished products correctly processed
and checked according to the defined procedures? |
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1.9 |
Are satisfactory arrangements existed to store
in appropriate storage conditions? |
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2.0 |
PREMESIS |
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2.1 |
(DESIGN & LAYOUT OF FACILITIES) Does the facility have proper design,
layout and finishes based on
contemporary standards to: |
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2.1.1 |
Manufacture high-quality medicine. |
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2.1.2 |
Avoidance of cross-contamination. |
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2.1.3 |
Proper cleaning, drainage and sanitizing. |
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2.1.4 |
Ventilation, air conditioning and
maintenance. |
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2.2 |
Is there an emergency power supply available
to take care of the entire energy demand or at least critical areas? |
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2.3 |
Does the facility have appropriate
controls to maintain required parameters e.g. temperature, relative humidity
and pressure differentials etc? |
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2.4 |
Are the doors, windows, walls, ceiling and floor such
that no holes or cracks are evident (other than those intended by design)? |
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2.5 |
PLANT SAFETY & SECURITY |
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2.5.1 |
Does the facility have safety program? |
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2.5.2 |
Are safety procedures written? |
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2.5.3 |
Do employees receive safety orientation before
working in the plant area? |
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2.5.4 |
Does the facility have a formal, written security
policy? |
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2.5.5 |
Is access to the facility restricted? |
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2.6 |
SANITATION |
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2.6.1 |
Is a written sanitation program available on the
premises? |
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2.6.2 |
Is the sanitation program implemented and effective in
preventing conditions? |
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3.0 |
PERSONNEL (STAFFING PLAN, STAFF
QUALIFICATION, EXPERIENCE, ON-THE-JOB TRAINING & HYGIENE) |
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3.1 |
Has the facility provided sufficient qualified
personnel to fulfill all its responsibilities required under the rule? |
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3.2 |
Has the facility provided Organization Chart? |
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3.3 |
Does the company have qualified, trained and
experienced staff required for managing? |
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3.4 |
Does the company have “On the job training program”
for technical staff? |
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3.5 |
Is the technical staff, including supervisors and
operations certified (and documented) in specialized training e.g. aseptic
technique, sterilizing, washing, dehydrogenation, visual inspection, standard
operating procedure etc. |
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3.6 |
HYGIENE |
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3.6.1 |
Are all the personnel undergone health examinations to
prior to employment? Are all the personnel provided health examinations during
employment? |
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3.6.2 |
Are workers conducting visual inspections undergoing
periodic eye examinations? |
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3.6.3 |
are the record maintained? |
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3.6.4 |
Are all personal aware of the principles of GMP
and received initial |
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3.6.5 |
and continued training including hygiene
instructions? |
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4.0 |
VALIDATION |
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4.1 |
Is validation properly documented and includes
Validation Master Plan, Validation Protocols, Validation Reports and
Equipment Qualified? |
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4.2 |
Are validation studies conducted in accordance with
pre-defined protocols? |
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4.3 |
Have production procedures been validated? |
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4.4 |
Does the process control address an issue to ensure the identity, strength, quality and purity of the product? |
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4.5 |
Does the procedure include formulation that is
written to yield not less than 100% of the established amount of active
ingredients? |
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4.6 |
Are all weighing and measuring performed by one
qualified person and observed by a second person and is dully signed by both
of them on record sheet? |
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4.7 |
Validation of New Master Formula: Is new master formula or method of preparation
adopted and steps taken to demonstrate its suitability for routine
processing, process defined materials and equipment specified? |
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4.8 |
Validation of Equipment & Materials: Are significant amendments to the manufacturing
process, including any change in equipment and materials affecting product
quality or re-productivity of process validated? |
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4.9 |
Are validation records properly maintained? |
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5.0 |
DOCUMENTATION / RECORDS |
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5.1 |
Are documentation meticulously maintained
as per rules and regularly reviewed and kept up to date? |
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5.2 |
Is documentation accurate, clear &
neat? Does it define specifications and procedures for all materials &
methods of manufacture & control? |
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5.3 |
Are all the specifications, testing
procedures, master formulae, packing instructions and standard operating
procedures (SOPs) available, current & being followed? |
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5.4 |
Do the records provide the existence of
documented evidence, traceability, and an audit trial that will permit investigation? |
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5.5 |
Does the record provide batch processing
& packaging details including receiving sample, processing equipment,
analytical testing and laboratory instrument records? |
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5.6 |
LABELS |
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5.6.1 |
Are labels to the containers, equipment
or premises applied un- ambiguously according to the company’s agreed format? |
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5.6.2 |
Are labels of different colors indicating
the status such as “Quarantined”, |
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5.6.3 |
Are all finished products are labeled as
per specification? |
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5.6.4 |
PROCESS DOCUMENTATION / RECORDS |
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Are following documents/record are
available: |
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Starting material re-assy. |
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Specifications for intermediate and bulk
products |
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Batch processing records |
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Record for process operation |
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Batch packaging records |
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Record for packaging operation |
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Record of Batch numbers |
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Analytical records of the batch Record
for finished product release procedure |
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5.7 |
STANDARD OPERATING PROCEDURES (SOPS) |
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Are SOPS and associated records of
actions, and conclusions reached available for the following at the premises? |
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Equipment assembly and validation |
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Analytical
apparatus and calibration |
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Maintenance, cleaning and sanitization |
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Personnel matters including qualification,
training, clothing and hygiene |
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Environmental monitoring |
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Pest control |
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Complaints |
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Drug recalls |
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Drug returns |
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5.8 |
EQUIPMENT LOG BOOKS |
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5.8.1 |
Are log books for major & critical equipment
identified by the company kept? |
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6.0 |
VENDOR
QUALIFICATION |
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6.1 |
Do you have list of approved vendors? |
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6.2 |
Are the vendors supplying raw material
(both active & inactive ingredients), empty gelatin capsules, primary
packaging & printed packaging components audited & found to be
satisfactory? |
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7.0 |
CHANGE
CONTROL PROGRAM |
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7.1 |
Is there a formal change control program
in place supported by an SOP to initiate, review & approve changes in
material, sources, processes, products packaging, equipment, batch size
changes etc. |
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8.0 |
SAMPLE |
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8.1 |
Does
the company retain a sample of lot or batch of the packaged/labeled drug
for a period of at least one year after the expiration date on the label of
the drug? |
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8.2 |
Does the company retain a sample of each
lot or batch of a raw material (including both active and inactive
ingredients)? |
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9.0 |
STABILITY
STUDIES |
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9.1 |
Does the company have a prospective and
concurrent stability studies program based on SOP and utilizing proper
equipment i.e. climatic chambers maintained at 30° C / 65% RH for ambient and
40° C / 75% RH for stress conditions and continuously monitored for
temperature & RH? |
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9.2 |
Is stability of finished products
evaluated and documented prior to marketing? |
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9.3 |
Does the stability data support shelf
life assigned to the product. Are any deviations in data reviewed and
appropriate steps taken in case of stability issues? |
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10.0 |
DRUG
RECALL |
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10.1 |
Do you have SOP for drug recalls? |
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10.2 |
If answer yes to the above did you have
any drug recall in the past 2 year? (Please also mention the name of
products) |
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11.0 |
ANNUAL
PRODUCT REVIEW |
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11.1 |
Is there a process in place to review
statistical data (i.e.: trend analysis, reworks, rejects, customer
complaints) of all the products manufacture during the year? |
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11.2 |
Provide name of the products manufactured
by you along with price list. |
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11.3 |
Provide the source of raw material for
individual products. |
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11.4 |
Do you export your products, if so then
to whom and mention the name of the products? |
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12.0 |
AUDIT
/ COMPLAINTS |
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12.1 |
INTERNAL GMP AUDITS |
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12.1.1 |
Do you have an effective internal GMP
inspection program to audit all the manufacturing areas, activities & QC
lab at specific defined periods? |
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12.1.2 |
Is there a process in place to fill the
gaps / observation / non-conformance found during the internal GMP audits? |
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12.2 |
QUALITY AUDITS |
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Is quality audit conducted by outside or independent
specials or a team designated by the management for the purpose? |
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12.3 |
COMPLAINTS |
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Are complaints and other information
concerning potentially defective products carefully reviewed according to the
written procedures? |
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13.0 |
QUALITY
CONTROL DEPARTMENT |
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13.1 |
Does the QC lab have SOPs to cover all
the functional areas? |
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13.2 |
Are adequate facilities and equipments
available for the physical, chemical & microbiological testing? |
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13.3 |
Are approved written procedures available
for sampling, inspecting and testing raw materials, packaging materials, in
process drugs, bulk drugs and finished products? |
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13.4 |
Are samples of starting material,
packaging material, intermediate products, bulk products and finished
products taken by methods and personnels approved by QC department? |
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13.5 |
Are in-process materials tested at
appropriate phases for identity, strength, quality, purity and are they
approved or rejected by Quality Control? |
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13.6 |
Are records of in- process controls
maintained? |
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13.7 |
Does each batch of drug product prior to
release confirms compliance of finished product specification? |
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13.8 |
Are validated & stability indicating assay
methods used? |
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13.9 |
Are reference standards used for the
assay? |
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13.10 |
Are accurate, clear & neat records
maintained along with the raw data for the entire analytical work? |
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14.0 |
MANUFACTURING AREA EQUIPMENTS, EQUIPMENTS, MATERIAL / COMPONENT |
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14.1 |
EQUIPMENTS |
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Does the company have suitable equipments
capable of producing consistent quality products? |
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Do the equipments meet contemporary
standards for the manufacture of pharmaceuticals i.e. smooth finishes, right
quality construction material for the intended purpose, easy to clean, wash,
sterilize etc. |
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Are the following pieces of equipments
suitable in their design/size & capacity? (Blends, Conveyors, Tablet
presses, Capsule fillers, Bottle fillers etc) |
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Does the equipments & facilities have
appropriate controls to maintain required parameters e.g. temperature,
relative humidity, pressure differentials etc? |
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Is the equipment cleaned promptly after
use? |
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14.2 |
EQUIPMENT/INSTRUMENTS CALIBRATION & PREVENTIVE
MAINTENANCE |
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Are written records maintained on
equipment cleaning, sanitizing and maintenance on or near each piece of
equipment? |
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Does the facility have approved written
procedures for checking and calibration of each piece of measurement equipment? |
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Are records of calibration checks and
inspections maintained in a readily retire able manner? |
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14.3 |
MATERIAL/COMPONENT |
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All handling of material and products
such as receipt, quarantine, sample storage, |
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All incoming materials and finished
products quarantined immediately after receipt or processing until they
released for use or distribution? |
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Are all materials handled in such a way
to prevent contamination? |
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14.4 |
RAW MATERIAL |
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Were the premises designed for storing
the raw material? |
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Does the store premises allow storage of
raw materials at various temperatures? |
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If answer yes to the above what are the
controls to log any irregularities? |
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What is the source of the active
ingredient used? |
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What are the source of additives used? |
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Is any documentation done at the time of
receiving the raw materials? |
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What is the process of communication with
the laboratory for a sampling of the raw material? |
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Is there a quarantine for storing
unreleased raw materials? |
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If so, what is the process? |
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What is the process of storage after the
raw material is released for use? |
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What is the process of issue of raw
material for manufacturing? |
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Who is responsible of issuing? |
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What is the process of revalidation of
balances? |
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What is the process of revalidation of
raw materials? |
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Do you have a standard operational
procedural manual for stores? |
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14.5 |
PURIFIED AND WATER FOR INJECTION SYSTEM |
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Does the facility have proper Purified
and Water for Injection System available? |
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Is water circulating in a continuous loop
and maintained at 80° C, 24/07/365? |
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Is quality of water monitored chemically
& biologically on daily basis? |
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Is purified water used in all oral
preparation & washing of equipment? Is water for injection used for all
sterile preparation, clean steam generation for autoclaving, final rinse of
machine parts and sterile container? |
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Are deionizers that feed water for
injection of two bed design and able to provide for continuous flow? |
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Are stills constructed of stainless
steel? |
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If yes what type? |
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Are still equipped with devices which
measure, record and automatically control conductivity? |
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Have the stills been passivated? |
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Are the holding tanks electropolished and
passivated? |
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Are the holding tanks electro polished
and passivated? |
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Are the holding tanks equipped with
heated or jacketed 0.2-micron hydrophobic filter? |
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Are the holding tanks capable of steam
sterilization at a minimum of 121° C? |
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Are holding tanks equipped tanks equipped
to maintain WFI at 80 °C? |
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Are the holding tanks equipped to supply
nitrogen through a 0.2-micron hydrophobic vent filter? |
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If WFI system constructed of stainless
steel 316 L or equivalent? |
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Is WFI system electro polished and
passivated? |
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Is there a continuous loop, single pass system? |
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Is the system sloped with dead legs no larger
than 6 pipe diameters? |
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Is the system fitted with diaphragm values? |
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Is the system capable of steam
sterilization? |
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Is the system capable of being maintained
at 80 °C with continous temperature monitoring devices? |
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Is the conductivity of WFI monitored on
return loop? |
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Are pumps constructed of stainless steel,
316 L or equivalent? |
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Do the pumps use WFI as seal lubricant? |
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Are pumps able to be completely drained? |
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What is the source of water to the
facility? |
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Well / City water / Treated / Untreated |
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Is testing performed on dionized water
system which supplies the NFI system? |
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What tests are performed? |
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How frequently are they performed? Are
the results documented? |
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Are there heat exchangers with in WFI
system? |
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What is the type of heat exchangers |
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316 L / Double sheet type/ double
concentric tube type? |
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What is the type and porosity of filters
within WFI system? |
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Which department performs the validation
of WFI system? |
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Was the validation approved by QC/QA? |
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Was the report issued and forwarded to worldwide
QC/QA? |
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Do you have SOP written for WFI? |
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Is WFI tested when used as raw material
as per testing standard Z 5576 requirements? |
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Are the results documented? |
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Are the all-use points in WFI system
tested as per testing standard Z 5576 on weekly basis? |
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Are the results documented? |
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Have microbial limits been established
for WFI samples? |
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What action plan exists in the event the
microbial limits exceed? |
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Is the investigation documented? What is
the porosity of membranes used in microbiological testing? |
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What nutrient media is used? |
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At what temperature and for how long are
WFI samples incubated? |
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After incubation how are results
documented? |
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Are any microorganisms that are isolated
from positive WFI samples gram stained and/or identified to genus/species? |
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Are standardized and validated autoclave
loads for nutrient media used for WFI testing? |
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Are growth support tests performed on
each lot of nutrient media that is used for WFI testing? |
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How is sterility verified for each lot of
nutrient media that is used for WFI testing? |
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How is nutrient media stored prior to
use? |
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Are there established routine maintenance/calibration programs for deionized and WFI systems? |
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14.6 |
DEPACK / PREPARATION COMPONENT ROOM |
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Is the depack room separate from the
component preparation room? |
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Does depack room have air conditioning
and local exhaust for dust control? |
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Is there a pass through between the
depack room and the component preparation room? |
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Is there a uniform change room outside of
the preparation component room? |
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Is access to the preparation component
room restricted? |
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What is the preparation component room
designated class? What is the efficiency of filters? % How many air changes occur per hour? |
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What type of water is supplied to washer
and sinks? |
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What is the validation process for the
washing of stopper & vials? |
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How are the silicone vials and stopper
tested for use? |
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Are Stopper and vials tagged with lot
numbers as such through sterilization/dehydrogenation and on through filling |
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How frequently are efficiency filters and
laminar flow hood heap filters tested? |
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Are the garments made of non- shredding
material? |
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What is the frequency of the garments
being sterilized? |
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14.7 |
STERILIZER / OVEN LOADING ROOM |
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What is the sterilizer / oven loading room designated
class? |
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What is the efficiency of filters? |
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How many air changes occur per hour? |
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Does the sterilizer meet the following criteria: |
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Is it capable of maintaining an empty chamber temperature
distribution of +/- 1° C at a steady state? Is there a double door design with interlock? |
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What is the size of vent filter? |
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Is it capable of using thermocouples in the chamber for
measuring load temperatures? |
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Is it equipped with a recording device
for checking temperature and pressure? |
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Is it equipped with a vacuum pump for the
removal of air from the load? |
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Is it equipped with a clean steam? |
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Does the oven meet the following
criteria? |
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Is it equipped with hepa filtered air? |
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Are there 2 inter locking doors? |
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Are there recirculating fans located
upstream of the HEPA filters? |
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Does it have the resistance temperature
device in the return air duct for control temperature? |
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Can it maintain an empty chamber |
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+/- 20 °C for sterilization? |
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Is it equipped with a temperature
recorder? |
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Can be fitted with additional temperature
probes for measuring loaded materials? |
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How frequently are the sterilizer and
oven calibrated and the results documented? |
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How frequently are the efficiency filters
integrity tested? |
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Are the results of the testing documents? |
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Are the garments made of non sharedding
material? |
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Are the garments washed and sterilized
after use? |
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How frequently are they sterilized? Are
the procedures validated for the sterilized/depyrogenated stoppers and
components? |
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|
Are biological or chemical indicators
used? |
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|
Are stoppers and components used for a
given lot of product traceable via a lot number to a specific sterilizer/oven
load? |
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|
How long can the of
sterilized/depyrogenated components be stored prior use? |
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|
Are the processes for storage of
sterilized /depyrogenated components validated? |
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|
Are the sterilizer and oven charts
reviewed by Quality Control prior to the release of sterile products? |
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Have restrictions been established for
the number of times that components may be sterilized /depyrogenated? |
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14.6 |
EQUIPMENT
AIRLOCK |
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|
Are the air lock doors interlocked double
room concept? |
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Is the airlock designated class 100,000? |
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|
Are there low-level air returns? What is
the air flow from? |
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|
Does the airlock have lights? Ultraviolet Infra-Red |
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||
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||
|
Is the airlock equipped for spray
sanitization? |
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|
What sanitizing agent is used? |
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|
14.7 |
WASHROOM / GOWN CHANGE ROOM |
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|
|
Is the wash room equipped with sink and
hot air hand drivers? |
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|
|
Does the wash room have lights? Ultraviolet Infra-Red |
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||
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||
|
Does the wash room have interlocked
doors? |
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|
|
Is there an airlock entry from the grown
change room into the |
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|
|
Sterile rooms? |
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|
|
Is the grown change room designed as
class 100,000? |
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|
Are garments made of non-shredding
material? |
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|
|
How frequently are they sterilized? |
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|
|
What sanitization agent is used? |
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|
14.8 |
MANUFACTURING (STERILE PRODUCTS) |
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|
|
Does the company have adequate
sterilizing, depyrogenating, sterile, filtration, processing, filling and
packaging equipment available? |
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|
|
Is there an adequate control of viable,
non-viable micro-organisms and effective routine monitoring of sterile area
and aseptic practices through use of reliable equipment? |
|
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|
|
Are sterile area air handling unit run
24/7 except for shut down due to routine maintenance to maintain sterile
environment? |
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|
14.9 |
ENVIRONMENTAL MONITORING |
|
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|
|
Are laminar flow hood and HVAC system
which serve the sterile operations areas validated? |
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|
Which department performs the validation? |
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|
|
Was the validation approved by QC/QA? |
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|
Was the report issued? |
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|
If yes, was the report forwarded to
worldwide QC/QA? |
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|
|
Is there an environmental monitoring
program for the aseptic batching area, sterile filling room, sterile filling
line and ancillary areas? |
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|
|
Is non-viable particulate sampling
performed? |
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|
|
How is viable air sampling performed? |
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|
|
How is surface sampling performed? |
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|
|
Is environmental monitoring equipment on
a maintenance / calibration program? |
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|
|
At what temperature for how long are environmental
monitoring samples incubated? |
|
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|
|
After incubation how are test results
documented? |
|
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|
|
What nutrient media is used for
environmental monitoring? |
|
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|
|
Are there standardized and validated
autoclave loads for nutrient media used for environmental monitoring? |
|
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|
|
Are growth support tests performed on
each lot of nutrient media that is used for environmental monitoring? |
|
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|
|
How is sterility verified for each lot of
nutrient media that is used for environmental monitoring? |
|
|
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|
|
How is nutrient media stored prior to
use? |
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|
14.10 |
ASCEPTIC BATCHING AREA |
|
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|
|
Is the area designated as class 10,000?
Are there terminal Hepa filters? |
|
|
|
|
What is the minimum of air changes per
hour? |
|
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|
|
Is the area capable of complying with the
maximum temperature (68° F) and humidity limits (50% RH)? |
|
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|
|
Do the laminar flow hoods provide class
100 air over the product? |
|
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|
|
Is all the product contact equipment in
the aseptic batching area sterilizable by hot air or steam? |
|
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|
|
Are the walls, floors and ceilings non
porous and sanitizable? |
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|
|
Are the doors self-closing without door
knobs? |
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|
|
Are the light fixtures and motors totally
sealed and enclosed? |
|
|
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|
|
Are the room air pressures, temperature,
humidity and filter pressure drop automatically monitored, alarmed and
recorded? |
|
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|
|
Do personnel sanitize their gloved hands? |
|
|
|
|
|
Are HEPA filters and laminar flow hoods
integrity tested? |
|
|
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|
|
If yes, how frequently? |
|
|
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|
|
Is equipment status labeled? |
|
|
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|
|
Are the results documented for the
equipments calibrated? |
|
|
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|
|
Are sterilization/clarification filters
integrity tested and results documented |
|
|
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|
|
What is the quality of water used for
equipment cleaning? |
|
|
|
|
|
Are tanks, hoses etc. sterilized prior to
use and are these procedures user validated? |
|
|
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|
|
Are tanks labeled during processing
indicating status of product? |
|
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|
|
|
Are asceptic operations performed using
laminar flow hoods? |
|
|
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|
|
Is sterile bulk sampled and tested as per
testing standard requirements? |
|
|
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|
|
Are sampling and testing complete prior
to or concurrent with the filling operation? |
|
|
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|
|
Is bulk held under positive pressure
after final filtration / sterilization? |
|
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|
|
How are gases sterilized? |
|
|
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|
|
Is sterile gas filters integrity tested
before and / or after use? |
|
|
|
|
|
How is bulk yield determined? Are batches
reprocessed? |
|
|
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|
|
If so, what are the written procedures? |
|
|
|
|
|
Is rework material routinely added to batches? |
|
|
|
|
|
14.11 |
FILLING ROOMS |
|
|
|
|
|
Is the filling room designated as class
10,000? |
|
|
|
|
What are the minimum air changes per hour? |
|
|
|
|
|
Are environmental systems designed to run
continuously? |
|
|
|
|
|
Is the area capable of complying with
maximum temperature (68 °F) and humidity limits (50%RH)? |
|
|
|
|
|
Do this laminar flow hoods provide class
100 air over product? |
|
|
|
|
|
Is the product contact equipment sterilized
by hot air or steam? |
|
|
|
|
|
Are the walls, floors and ceilings non-
porous and sanitizable? |
|
|
|
|
|
Are the doors self-closing without door
knobs? |
|
|
|
|
|
Are the light fixtures and motors totally
sealed and enclosed? |
|
|
|
|
|
Are room air pressure, temperature,
humidity and filter pressure drop automatically monitored, alarmed and
recorded? |
|
|
|
|
|
Are the filling lines designed with
laminar flow hoods to provide class 100 air at the rate of 90feet/minute at
the product height? |
|
|
|
|
|
Are surfaces of laminar flow hood made of
stainless steel? |
|
|
|
|
|
Is the filling line equipped with
continuous non-hinged, non-shedding sanitizable belt or conveyor system? |
|
|
|
|
|
Is the filling line equipped with
automatic filling and stoppering equipment? |
|
|
|
|
|
What sanitizing agent is used to sanitize
gloved hands? |
|
|
|
|
|
Are Hepa filters and laminar flow hoods
integrity tested? If yes, how frequently? |
|
|
|
|
|
How is the product delivered from aseptic
batching area to the filling lines? |
|
|
|
|
|
Is the sterile bulk filtered on line? |
|
|
|
|
|
Is the sterile filter integrity tested
before and/or after use? |
|
|
|
|
|
Is the porosity and type of filter
included with the batch records? |
|
|
|
|
|
Are results of filter integrity test
included with the batch records? |
|
|
|
|
|
Is bulk held under positive pressure
during filling operation? |
|
|
|
|
|
How are gases sterilized? |
|
|
|
|
|
Are asceptic operations performed using
laminar flow hoods? |
|
|
|
|
|
How is the filling figure determined? Is
the fill volume checked during filling operation? |
|
|
|
|
|
Are the results documented? |
|
|
|
|
|
What action is taken when filling limits
are exceeded? |
|
|
|
|
|
Are vials flooded with nitrogen? Where
are the vials capped? |
|
|
|
|
|
Are rejected vials reprocessed? |
|
|
|
|
|
If so what are the written procedures? Is
QC/QA informed of manufacturing problems that could affect product quality?
(Alert Notice System). |
|
|
|
|
|
What is the quality of water used for
equipment cleaning? |
|
|
|
|
|
What filling equipment parts are
sterilized /depyrogenated in an autoclave oven prior to use? |
|
|
|
|
|
Have these processes been validated? How
frequently are the filling line (including accessories) sanitzed? |
|
|
|
|
|
What sanitization agents are used? |
|
|
|
|
|
Are the procedures validated and
documented? |
|
|
|
|
|
Is a filling line use record kept? |
|
|
|
|
14.12 |
SANITIZATION OF STERILE ROOMS |
|
|
|
|
|
How frequently is the sterile area
sanitized? |
|
|
|
|
What areas are sanitized? Floor / Wall /
Ceilings |
|
|
|
|
|
What sanitizing agents are used? Are
sanitizing agents rotated? |
|
|
|
|
|
Are sanitizing agents prepared with WFI
and filter sterilized prior to use? |
|
|
|
|
|
How is it applied to surfaces? |
|
|
|
|
|
Is sanitization agent allowed to dry and then
rinsed off with WFI? |
|
|
|
|
|
Is sanitization documented? |
|
|
|
|
|
14.13 |
INSPECTION |
|
|
|
|
|
Are filled vials inspected for
particulars and container defects prior to packing? |
|
|
|
|
What percentage of batch is inspected? |
|
|
|
|
|
Are the types of rejected vials
documented? |
|
|
|
|
|
Are rejected vials reprocessed? |
|
|
|
|
|
Is there a written procedure for handling
rejected vials? |
|
|
|
|
|
Are inspectors trained? |
|
|
|
|
|
Is the training documented? |
|
|
|
|
|
Do inspectors receive an eye examination? |
|
|
|
|
|
If yes, how frequently? |
|
|
|
|
|
14.14 |
TERMINAL STERILIZATION |
|
|
|
|
|
Are any products terminally sterilized? |
|
|
|
|
Are biological indicators used in sterilization
process? |
|
|
|
|
|
14.15 |
PACKAGING |
|
|
|
|
|
Is the packaging line equipped with
capping equipment? |
|
|
|
|
If so then with semi-automatic or
automatic? |
|
|
|
|
|
Are line, clearances performed and
documented? |
|
|
|
|
|
Is there adequate packing indicating
status of product? |
|
|
|
|
|
Is the line labeled during packing
indicating status of product? |
|
|
|
|
|
Are QC inspectors checking and
documenting the packaging operations? |
|
|
|
|
|
Are rejected vials reprocessed? |
|
|
|
|
|
Are the number of packaged containers
reconciled with the amount of filled containers that were delivered for
packaging? |
|
|
|
|
|
Is the reconciliation documented? |
|
|
|
|
|
Upon completion of packaging, are the
labels, inserts and cartons reconciled? |
|
|
|
|
|
14.16 |
MANUFACTURING (ORAL DOSAGE FORM) |
|
|
|
|
|
What is the receiving process of raw
material from the stores? |
|
|
|
|
Where is the raw material stored after
being issued from the stores? |
|
|
|
|
|
Does the QC validate the water used
during the manufacturing process? |
|
|
|
|
|
What is the source of water? |
|
|
|
|