• 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

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