DOCUMENTATION IN PHARMA
- Well-established documentation system exists to implement Good Documentation Practices, which is a part of Quality Assurance.
- Clearly written documents are prepared, reviewed and controlled, which prevents the errors from verbal communication and permits traceability for all activities carried out.
- Quality Assurance is responsible for the revision and distribution of documents and concerned departments are responsible for preparation and initiation of changes in procedure.
- Master documents are stored in the archives of Quality Assurance department and controlled copies are distributed to the concerned departments.
- The documents are designed, prepared, reviewed, and controlled as per the SOP(s).
- Documents are approved and authorized, signed and dated by the designated persons.
- The documents specify the title and nature, also mention the purpose, they are laid in an orderly fashion.
- Reproduced documents are clear and legible and are appropriately stamped. These are normally reviewed as per the review period mentioned in the relevant SOPs.
- An SOP is required for the correction of a wrong entry in a record.
- The batch production and control records are completed at the time of each operation in such a way that all significant activities concerning the manufacture of the product are traceable.
- Batch records are retained for two years after the date of expiry of the relevant drug product.
- SOP is available for issuance, traceability during storage, retrieval, and destruction of records.
- Any change in the approved documents is processed through a system of Change Control.
- Different types of master documents and records required with the company are listed below:Site Master File, Master formula Record, Process Validation, Batch Manufacturing Records.
- Validation Master Plan, Validation Protocols and Reports, Stability Protocol and Reports.
- Standard Operation Procedures, Specifications (Raw Material, In-process Material, and Finished Product), Standard Test Procedures, and Analytical Method Validation.
- All the documents are controlled by the Documentation Cell of the Quality Assurance department.
- The system is designed to ensure that all the documents are properly distributed, controlled and stored so as to maintain their integrity.
- The access to stored documents is limited to the authorized persons only and all documents are stored in such as way so that they are easily retrievable.
- Any other Documentation Related to Product Quality that is not mentioned elsewhere Other related documents are also available. These are:
- Annual Product Reviews
- Internal Audit Reports
- Calibration Records of instruments
- CAPA (Corrective and Preventive Actions)
- Change Controls/ Deviations Records
- Cleaning and sanitization records
- Disposal Procedures and their Handling
- Induction Manual
- Investigation Reports for Product Complaints
- Non Conformance Reports (NCRs)
- Qualification documents like URS, DQ, IQ, OQ and PQ of Equipments/ Instruments.
- Vendor Approval records
- Sampling Procedures
- Training Evaluation Records
- User Requirement Specifications (URS)
- Reports of water samples and other routine microbiological testing
- Safety Manual
