• 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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About Abha Maurya

Abha is the Author of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in the pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, and Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008, and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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