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SOP for Production Activities as per Safety & cGMP Requirement

Purpose
To provide guideline to ensure that different production activities are carried out in compliance with safety & cGMP requirement, at pre-determined frequency.

Objective
To provide a documented guideline to ensure that different production activities are carried out in compliance with safety & cGMP requirement, at pre-determined frequency.

Scope
The scope of this SOP covers all the production disciplines.

Responsibility
Primary: Officer Production
Secondary: Executive Production

Procedure

Organisation & Function
  • The department must have a team that would perform all the function meeting cGMP requirements. It must also address documentation, audits and training aspects of production jobs.
  • The production department organization must be structured to ensure that production functions are carried out safely, in accordance with cGMP requirements, efficiently and promptly to support other service areas. It must be resourced with adequate numbers of appropriately qualified and trained staff.


Prevention of Contamination and Cross-Contamination
  • Before starting any process in equipment make sure the equipment should be cleaned and line clearance has been given by QA.
  • The production area should be clean and free from dust and dirt so the intermediate and final product could not be contaminated.
  • The cleaning of the production area should be looked after by the QA department.

Training
  • All the staff shall be covered for cGMP, Safety, and Job-related training as per the training procedure.

Standard Operating Procedure
  • SOP must be prepared for all activities that are quality critical or safety-critical or relate to key business areas. These SOPs must be prepared, reviewed & authorized and controlled in accordance with Site SOP.
  • The SOPs must include specific maintenance instructions, lubrication details, Spares requirements, frequency of maintenance, responsibilities for carrying out the job & documentation, etc. as appropriate. The department activities must be reviewed to identify operations which need preparation of SOP and the current SOPs must be updated / reviewed as scheduled.

Audits
  • Department audits must be carried out to monitor the production aspects of departmental activities in regard to its impact on SHE, Energy Conservation and Quality matters.

Validation
According to the cGMP requirements, process validation should be done.


Change Control
  • All changes must be fully documented, assessed and authorized prior to the work being carried out.
  • In line with good documentation practice, changes in the process must be controlled as per good manufacturing practices. If any Change occurs it should be reported to the QA department with reason.

Documentation
  • A separate list must be made for numbering and authorization documents.
  • The documents will include the following:
  1. Batch Manufacturing Record: Documentation pertaining to BMR is to give information about progress in the production of intermediate as well as final finished products including every information regarding to the product like an analytical report, condition of reaction given for reactor etc.
  2. Equipment Cleaning Record: Before conducting the next step in the process cleaning of equipment should be required. To follow cGMP ECR should be filled by the production department before starting every process. By checking ECR, the QA department gives line clearance to the production department.
  3. Validation Documents: Documentation pertaining to validation would include protocol and reports for DQ, IQ, and OQ activities and would be in line with the guidelines. Protocols and reports must also include the supplier’s documentation (e.g. pressure test, calibration certificate, etc.) besides the reports generated at site.

Abbreviation
SOP: Standard Operating Procedure

Annexure
Nil

Revision History
Nil

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