Personnel and Company Background Part I |
Supplier Name, address and telephone number |
Address and telephone number of supplier agent in the US |
Company representative and title |
Please provide a list of products you produce: |
How many employees at this location work in the Production and the Quality Unit? Production Quality Unit Full-time ________ _________ Part-time ________ _________ Temporary ________ _________ Contract ________ _________ |
Personnel and Company Background
Part II |
YES |
NO |
N/A |
Is the facility registered with
the FDA? If yes, what type of registration? |
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Has the facility ever been
inspected by the FDA? If yes, when was the last
inspection? |
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Has the facility ever been
inspected by the state department of health/agriculture? If yes, when was the last
inspection? |
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Are materials such as penicillin,
cephalosporin, agrochemicals, steroids cytotoxics, pesticides, etc. produced
at or in proximity to this location? If yes, what precautions are taken
to avoid cross contamination? |
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Are standards for personal
cleanliness listed in written SOPs? |
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Does each employee involved in the
manufacture, packaging, testing, and distribution of the materials /products
have a written job description? |
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Does each employee involved in the
manufacture, packaging, testing and distribution of the materials / products
have written records of the training and education received? |
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Is the employee training program
in writing? |
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Does the training program address
GMP training for new employees? |
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Does the training program address
GMP training for veteran employees? |
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Does the training program address
job/task training? |
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Does the training program address
SOP and documentation training? |
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Are internal GMP audits conducted
at the facility? |
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Facility and Grounds |
YES |
NO |
N/A |
What is the square footage and age
of the facility? |
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Are there written SOPs describing
the maintenance of the facility grounds? |
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Is the facility designed and
constructed to have adequate space for all operations, to assist with
the cleaning and maintenance, and to minimize the potential for
mix-ups? |
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Are any of the doors located in
the processing areas able to directly access the outside of the
facility? |
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Is suitable lighting available in
all production and warehouse areas for the task to be performed? |
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Are lighting fixtures equipped
with protective covers? |
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Do ventilation and air filtration
systems, and temperature / humidity controls exist in areas where it is
required to prevent contamination and/or adulteration? |
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Are trash receptacles properly
identified and maintained? |
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Are the materials used in the
construction of the facility’s floors, walls, ceilings, and work
surfaces easy to be cleaned, sanitized, and maintained? |
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Are there written SOPs describing
the types of cleaners and sanitizers to be used, with instructions for
use and proper storage? |
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Are there written records
documenting the cleaning of each processing room / area? |
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Does the facility have a pest
control program for the exterior and interior of the facility? |
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Is the individual responsible for
the pest control inspections trained and licensed? |
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Are there written records of the
pest control inspections? |
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How often to inspection occur? |
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Is potable or better-quality water
used in the following functions? Cleaning
Processing Hand-washing
Drinking
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What is the source of water used
in the facility? Municipal Water. |
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Are toilet and hand-washing
facilities readily accessible to all employees? |
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Do the doors from the toilet
facilities open directly into processing areas / rooms? |
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Are all toilet and hand-washing
facilities equipped with running water, soap, and towels or hand dryers? |
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Are hand-washing facilities
located in each area of the facility where hand-washing is required by the
employee’s duties? |
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Are hand-washing facilities
equipped with devices or fixtures that prevent recontamination of cleaned
hands? |
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Who is responsible for the overall
sanitation program at the facility and what is his/her title? - QA
Manager |
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Are all equipment cleanable in
design and construction and installed in such a manner to facilitate
cleaning? |
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Are equipment and utensils cleaned
as frequently as necessary using safe cleaning and sanitizing agents? |
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Are non-food handling equipments
kept in good state of cleanliness and repair? |
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Are tools and food handling
equipments properly stored when not in use? |
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Are conveyors and other food
transport systems clean and well-maintained? |
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Is non-food handling equipment
kept in good state of cleanliness and repair? |
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Are tools and food handling
equipment properly stored when not in use? |
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Are conveyors and other food
transport systems clean and well-maintained? |
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Are food-approved cleaning agents
and sanitizers being used? |
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Are cleaners and sanitizers stored
away from the processing area when not in use? |
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Equipment
and Utensils |
YES |
NO |
N/A |
Have precautions been taken to
ensure equipment is installed in a manner that assists with cleaning and
maintenance? |
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Is all equipment and utensils that
come into contact with the materials /products composed of stainless steel,
non-reactive plastics, or some other inert material? |
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If compressed air or gases are
used during the processing, is the quality monitored to ensure no moisture or
oil is in contact with ingredients? If yes, how often does this
monitoring occur? |
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If processing uses critical
process control /measuring equipment, is the equipment calibrated to ensure
accuracy? If yes, how often does this occur? |
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Are there written records
documenting the calibration? |
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Who is responsible for reviewing
the completed calibration records? |
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Are there written records
documenting the use and cleaning of all major pieces of equipment? |
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Who is responsible for reviewing
these completed records? |
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Are there written SOPs describing
the preventative maintenance activities for all major pieces of equipment? |
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Are there written records
documenting the maintenance activities? |
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Who is responsible for reviewing
these completed records? |
Quality Unit Activities |
YES |
NO |
N/A |
Does a quality unit exist at the
company?
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Who is the head of the quality
unit at this location and what is his/her title?
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Is there written SOP describing
the responsibilities and authorities of the quality unit?
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Does the quality unit have the
authority to approve /reject the following: Procedures…………………………………………………………………………. Specifications……………………………………………………………………… Test methods and
results………………………………………………………… Raw
materials……………………………………………………………………… Finished
products…………………………………………………………………. In-process
materials………………………………………………………………. Packaging
materials………………………………………………………………. Labeling……………………………………………………………………………. Formulas…………………………………………………………………………… Processing
records………………………………………………………………. Forms and
documentation………………………………………………………..
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Does the quality unit have final
review and approval for the selection of all suppliers and raw materials? |
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Are the suppliers audited as part
of the qualification process? If yes, by company personnel or by
a 3rd party?
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Is supplier compliance to
specifications monitored?
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Does the company have an internal
laboratory?
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Are contract laboratories used?
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Is there written SOP describing
the selection and approval of contract laboratories?
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Are there written test methods for
analyses performed?
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Who provides the test methods? Internally
determined
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Are there written records
documenting all testing performed?
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Are all test methods used,
compendial or internally developed, appropriately validated to provide
reliable and reproducible results?
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Is there a written SOP describing
how test methods are validated?
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Is there a written SOP describing
the performance of stability studies for existing and new products?
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Is there a written SOP describing
the preparation, review and approval of stability study protocols?
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Do all products have stability
data to support the assigned expiration dating? If not, explain how expiration
dates are assigned.
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Under what conditions are
stability studies performed?
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What regulatory guidelines are
followed in the perfomance of stability studies? |
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What occurs if a failure happens
during a stability study?
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Product Retrieval: |
YES |
NO |
N/A |
Are there written procedures for: An effective monitoring and
retrieval system for food and feed products produced, packaged, or
distributed, including...? …A defined retrieval team with
identified back-ups? …the routine monitoring of
customer complaints? …maintaining documentation of lot
coding on all raw materials, processing aids/ingredients, production batches,
and final products? …maintaining shipping records
capable of locating all product within 6 hours? …maintaining a current list of all
customers with names, 24-hour phone numbers, fax numbers and their back-ups Practicing a retrieval annually? |
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Are there adequate retain samples
to conduct thorough analytical investigations in the case of product retrievals?
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Purchasing: |
YES |
NO |
N/A |
Are there written procedures for: Ensuring safe purchasing of raw
materials, processing aids, ingredients, and packaging materials,
including…..? …written specifications for all
raw materials, processing aids, ingredients, and direct contact packaging
materials? …documentation of suppliers'
agreement to all requirements? The receipt, identification,
examination, handling, sampling, testing, and approval/rejection of all raw
materials, processing aids, ingredients? The inspection of all raw
material, processing aid, ingredient containers upon receipt? The inspection of all raw materials, processing aids, ingredients
for extraneous matter (filth, insect), microbiological contamination, and
aflotoxins or other toxins, as appropriate? Ensuring that each lot of raw
materials, processing aids, ingredients, and packaging materials is
identified with a unique lot number, given a status (e.g. quarantined,
approved, rejected) and properly released for use? The identification and control of
rejected raw materials, processing aids, ingredients, and packaging
materials?
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MANUFACTURING |
YES |
NO |
N/A |
Are there written SOPs describing
the receipt, identification, examination, handling, sampling, testing, review
/approval, and storage of raw materials?
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Are raw material containers
inspected at time of receipt?
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Are the raw material containers
identified according to status – quarantined /
released?
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Are raw materials examined for
possible filth, insects, microbial contamination, or other possible
adulterants? If yes, is the examination
recorded?
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Who is responsible for reviewing
these records? Where are these records
maintained?
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Is the Certificate of analysis
accepted in place of testing? If yes, what testing is not
performed?
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Are raw materials rotated
according to the FIFO (first in, first out) and FEFO (first expiration date,
first out)?
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Are raw materials that have been
stored for an extended time re-tested? If yes, what is the re-test
interval? If yes, what testing is performed?
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Are rejected raw materials
properly controlled and identified to avoid possible mix-ups with released
materials?
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Are raw materials, in-process
materials, and finished products segregated during processing and/or storage
to avoid potential mix-ups?
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Is there a master production
record for each finished product produced?
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Do these master production records
include the following: Raw material name List and amounts of all materials
to be used in processing Processing instructions Total theoretical amount of
processed product to be obtained Acceptable yield limits Description of the finished
product packaging and labeling
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Is there a processing record
generated for each batch of product to be processed? If yes, who is responsible for
issuing this record?
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Are there written specifications
for finished products?
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Is there a written SOP for
reprocessing of any products?
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Is the finished product identified
with a lot number allowing traceability of the history of the batch and its
processing?
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Are finished product containers
inspected for correct lot number and label prior to distribution?
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Are retained samples kept for all
raw materials and finished products? If yes, how long are they
retained?
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Is there a written SOP describing
the final review and approval of finished products for release prior to
distribution?
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Who is responsible for performing
this release?
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Is there a written SOP describing
how processing changes are reviewed, approved, and implemented?
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Is there a written SOP describing
the handling of customer complaints?
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Are there written records
documenting the customer complaints and investigations?
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Who is responsible for reviewing
these records? Where are these records
maintained?
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Is there a written SOP describing
the handling of product recalls?
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Are the records relating to the
receipt, sampling, testing, processing and distribution of products retained for
at least 1 year beyond the expiration date of the product?
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If the product does not have an
expiration date, are these records maintained at least 3 years after
processing?
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Warehousing and Distribution |
YES |
NO |
N/A |
Are finished products stored in
the warehouse identified according to status – quarantined / released?
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Are there written records
documenting the distribution of finished products?
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Do you use tamper evident seals or
locking devices on finished products being transporter?
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Where are these records
maintained?
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Do these records include the
following information? Order and ship
date……………………………………………………………… Customer name and
address………………………………………………… Product lot numbers and package
sizes………………………………… Identification of personnel who
filled the shipping order……… Identification of the carrier used
to transport the product…..... |
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Is there a written SOP describing
the identification, handling, examination and disposition of returned
products?
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Are there written records documenting the receipt, handling, examination, and disposition of returned products?
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Who is responsible for reviewing
these records? Where are these records
maintained?
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Are finished products distributed
in a FPFO (first processed, first out) and/or FEFO (first expiration date,
first out) manner?
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Is the warehouse clean and
well-maintained?
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Are proper precautions taken to
ensure transport carriers do not adversely affect the condition of the
ingredients? |
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What precautions are taken?
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Computer Systems |
YES |
NO |
N/A |
Are computer systems used for GMP
required systems or documentation? If yes, what functions does the
computer systems control / manage?
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Has the computer hardware and
software been validated?
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Are paper records maintained of
the data input into the computer system? Which are considered the primary
records?
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Is there a written SOP describing
the operations of the computer system?
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Is there a written SOP describing
the safety and security measures of the computer system?
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Does the computer system adhere to
Part 11 requirements for electronic records?
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Are routine back-ups performed to
prevent accidental loss of data? How often do the back-ups occur?
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Validation Activities |
YES |
NO |
N/A |
Does the company have a master
validation plan?
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Is there a written SOP describing
the preparation, review, approval and issuance of validation protocols?
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Has facility systems
qualifications been performed?
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Has equipment IQ, OQ, and PQ
validations been performed? If yes, which pieces of equipment
have been validated?
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Has process validation been
performed for all products produced?
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Has cleaning validation been
performed? If yes, what cleaning procedures
have been validated?
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What items are tested for in the
cleaning validation?
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Have all test methods used been
validated?
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Is there a written SOP describing
when re-validation must occur?
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Product Security: Are there
written procedures for: |
YES |
NO |
N/A |
Product security programs? |
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transportation (seals,
inspections, etc….)? |
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securing critical areas of
production and distribution, including final product storage, |
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raw material/packaging storage
areas, warehouses, 3rd party facilities? |
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control programs for the receipt
of all raw materials, processing aids, ingredients, and direct contact
packaging materials? |
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…Lot coding (to track material
flow into finished products)? |
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…product retrieval systems? |
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Air: are there written procedures
for: |
YES |
NO |
N/A |
Air quality, including…..? ...having air compressors, UV air
filters, critical air handling systems in PM program ...filters on all air compressors ...positive pressure environments
where product is exposed to the plant environment ...food grade lubricants on
compressors where air compressed air is expected to contact finished product ...point of use filters where
compressed air enters product contact areas |
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Product Retrieval: Are there
written procedures for: An effective monitoring and
retrieval system for food and feed products produced, packaged? |
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Allergen Control Includes: milk and milk
derivatives egg and egg derivatives peanuts (groundnuts) Tree-nuts Soy and soy derivatives Wheat and wheat derivatives Fin fish and fish derivatives Shellfish including
crustaceans Are there written procedures for: Reducing the risk of incidental
co-mingling of allergens, including...? ...separate storage of allergenic
vs. non-allergenic raw materials, ingredients, and processing aids. …dedication of utensils used only
for allergenic raw materials, ingredients, and processing aids? …cleaning of equipment used for
both allergenic and non-allergenic processing? Properly identifying allergens for
the purpose of labeling? |
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Lot Coding and Product Labeling: |
YES |
NO |
N/A |
Are there written procedures for: Ensuring proper traceability and
labeling of finished products, including ...lot coding on individual
packages or containers? …lot coding on Bill of Ladings for
bulk shipments? ...a lot code that identifies
date, location of manufacture? …legend to interpret lot, batch
codes? …legibility of batch, lot codes? …compliance with pertinent
regulations? The documentation of batch, lot
numbers for all processing aids, ingredients, and direct packaging materials
identified into the production process? The receipt, examination, and
storage of incoming labels and labeling materials? The receipt, examination, and
storage of packaging materials? Ensuring the correct labels and
packaging materials are used? A final examination of packaged,
labeled product for correct label and lot number? Handling unlabeled, packaged
finished product?
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Name and Title of person completing
this form:
____________________________________________
Name / Title
___________________ _________________
Signature: Date
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