Documentation is the cornerstone of any company’s Quality Management System and is an essential GMP requirement. Good Documentation Practice is critical that anyone dealing with GMP documents and documentation systems understands the regulatory requirements.
Requirement of Good Documentation Practice?
Good Documentation Practice is essential for Proof of invention, Company operations, Technology Transfer, Regulatory Requirements, and Liability Protections.
The Documentation System is What needs to get documented, What should get documented, Ensuring comprehensive documentation, Avoiding contradiction in documents, and Document control.
Directive Documents are Specifications, STPs, SOPs, Master Batch Records, and Validation Protocols.
Data Collection Documents like Production Batch Records, QC Records – COA, Validation Records, Equipment and Facility Logbooks, Calibration and Maintenance Records, and Vendor History Files.
Reports likes, Validation Reports, Facility Qualification Reports, Product Development Reports, and Process Flow Diagrams.
Related: GMP/cGMP Principle
Understand Good Documentation Practice in pharma:
- Good Documentation Practices help organizations to efficiently create and control documents across all parts of their business.
- GDP provides legal Proof that work was adequately planned and performed at the claimed time. It helps in troubleshooting technical and managerial problems. It provides a written history of the company and its products, and it provides to regulators that the company follows its commitments.
- GMP documents must be clear, comprehensive, not overlapping in their content, and must cover all essential aspects in sufficient detail. Documentation failure comprises a significant percentage of non-conformances during GMP audits. Develop standards for preparing documentation and establishing the document structure. There must be an Outline guideline for reviewing and correcting documentation and improving the review and approval process. Develop strategies to revise existing documentation.
- Write concise documents that are user-friendly. A document numbering method should be agreed upon to simplify and standardize tracking and minimize confusion due to frequent changes. Careful planning is required to manage links and referrals between documents to ensure that an approved document does not refer to an unapproved one. Too many referrals in documents may result in operational problems; it is helpful to review the referrals to determine if they are necessary.
- Documents shall specify the Title, Purpose/ Objective, and Scope. Reproduced documents should be clear and legible. Any alteration made in the entry of a document/ record shall be signed and dated if there is an alteration of any critical result or value that must be reasoned out. Recording of data must be concurrent.
SOPs and Records:
Receipt of Materials;
Standard Operating Procedures and records Shall be written for the receipt of each delivery of raw, primary, and printed packaging material.
The records of the receipts shall include;
- The detailed information of material Name on the delivery items and the container numbers.
- The date of receipt.
- The Name of manufacturers and suppliers.
- The manufacturer’s batch or reference number.
- The total quantity, and the number of containers, quantity in each container received.
- The control reference number is assigned after receipt.
- Any other relevant comment or information.
- As appropriate, there shall be written standard operating procedures for the internal labeling, quarantine, and storage of starting materials, packaging materials, and other materials.
- Standard Operating Procedures shall be available for each instrument and equipment, which shall be placed near the related instrument and equipment.
- There shall be written Standard Operating Procedures for sampling, including the person(s) authorized to require the samples.
- The sampling instructions shall include:
- Sampling method and sampling plan.
- The Name of the equipment to be used.
- Any precautions to be observed to avoid contamination of items or materials or any deterioration in their quality.
- The number of samples to be taken.
- The types of sample containers to be used.
- Any specific precautions to be observed, especially regarding sampling of sterile or hazardous material.
- There shall be Standard Operating Procedures describing information detail of the batch (lot) numbering found out to ensure that every batch of intermediate, bulk, or finished product is identified with a specific batch number.
- Batch numbering standard operating procedures applied to a processing stage and the respective packaging stage shall be the same or traceable to demonstrate that they belong to one homogenous mix.
- Batch number allocation shall be immediately recorded during a logbook or by an electronic processing system. The record shall include the date of allocation, product identity, and size of the batch.
For Good Documentation Practice, There shall be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed shall be recorded.
Records of analysis:
- The records shall include the following data:
- Name of item or product and, therefore, the dosage form.
- Batch number and, where appropriate, the manufacturer and supplier.
- References to the relevant specifications and testing procedures.
- Test results, including observations and calculations, and regard to any specifications (limits).
- Dates of testing:
- Initials of the persons who performed the testing.
- Initials of the persons who verified the testing and, therefore, the detailed calculations.
- A statement of release or rejection.
- Signature and date of the designated responsible person.
- There shall be written standard operating procedures and the associated records of actions taken for:
- Equipment assembly and validation.
- Analytical apparatus and calibration.
- Maintenance, cleaning, and sanitation.
- Personnel matters include qualification, training, clothing, and hygiene.
- Environmental monitoring.
- Pest control.
- Recalls made.
- Returns received.
- For Raw materials and packaging materials. They shall include:
- The designated Name and internal code reference.
- Reference, if any, to a pharmacopoeial monograph.
- Qualitative and quantitative requirements with acceptance limits.
- Complete information with address with original material supplier.
- Specimen of printed material.
- Sampling direction and testing or procedures with reference.
- Storage conditions; and a maximum period of storage before re-testing.
- For Product Containers and Closures– Whenever bottles are being used, the written schedule of cleaning shall be laid down and followed. Where bottles after washing are not dried, use of types of water such as de-ionized water or distilled water to rinse them, as the case may be.
- Specifications should be available for in-process and bulk products for in-process material, intermediate, and bulk products. The specifications should be verified.
- For Finished Products – Dedicated specifications shall be included for finished products:
- The Name of the product with item code reference.
- The formula with its reference.
- Sampling direction and testing or procedures with reference.
- Description of the dosage form and package details.
- The acceptance limit of materials and qualitative and quantity requirements.
- The storage conditions and precautions, where applicable, and the shelf-life.
Master Formula Records:
Master Formula Records– The procedure with details of the products ( product name and batch size) shall be included in master formula records. The technical staff shall be included in its preparation, i.e., the head of a production and quality control. The Master Formula shall include:-
- The Name of the product with item code reference relating to its specifications.
- The product’s patent and the detail of generic Name, dosage form description, strength, the product composition, and size batch.
- Starting materials with Name, quantity, and reference number of all to be used.
- A statement of the expected final yield with the acceptance limits and relevant intermediate yields, where applicable.
- The methods to be used for preparing the critical equipment include cleaning, assembly, calibration, and sterilization.
- Detailed stepwise processing instructions and the time is taken for each step.
- The instructions for in-process controls with their limits.
- Storage conditions requirements for the products, including the container, labeling, and special storage conditions where applicable.
- No special precautions are to be observed.
- Packing details and specimen labels.
There shall be authenticated packing instructions for every product and their pack size with type. These shall include the following:
- Product name with information with a detailed description of dosage form, strength, and composition.
- The pack’s size is expressed in terms of the number of doses, weight, or volume in the final container.
- Complete a list of all the packing materials required for standard batch size, including quantities, sizes, and types, with the item code or reference number relating to the details of each packing material.
- Reproduction of the relevant printed packing materials and specimens indicating where the batch number and expiry date of the product have been applied.
- Special procedures and precautions to be followed like area and instruments to confirm the line clearance before the operations begin.
- Description of the packing operation, including operations and equipment to be used.
- Details of controls of in-process with instructions for sampling and its procedure.
- Upon completion of the packing and labeling operation, a reconciliation shall be made between the number of labeling and packaging units issued, the number of units labeled and packed, and the excess returned or destroyed. any unusual discrepancy in the numbers shall be carefully examined before releasing the final batch.
Batch Processing Records:
- There shall be a Batch Processing Record for each product. The method of preparation of such records included in the Master Formula with the method of preparation records shall be designed to avoid transcription errors.
- Before starting any process, ensure that the equipment and workstation are clear of previous products, documents, or materials not used or unplanned are removed and that equipment is clean and suitable for use.
- During processing, the following information like each action shall be stored or recorded along with dated and signed by the person responsible for the processing operations:
- The Name of the product.
- The number of the batch being manufactured.
- Sign of the operator of different production steps and the person who checked each of these operations.
- The b.no. Furthermore, the analytical control number and the quantities of all the materials were weighed.
- Record the control in-process and the sign with the date of the person involved in carrying them out and the results.
- The yield is obtained at a different stage.
- If the yield obtained is less than the recommendation, it should be comments or explanations for significant deviations.
- If any deviation from the master formula, it must be with special notes with a signed authorization.
Related: Pharmaceutical Audit
Documentation and Records:
Good Documentation Practice is an essential part of the QA system and, as such, shall be associated with all aspects of Good Manufacturing Practices (GMP). It aims to define all materials’ specifications, including manufacturing methods and control, to make sure personnel concerned with manufacturing are knowledgeable. The person should decide whether or not to release a batch of a drug purchasable and supply an audit trail that shall permit investigation of the history of any suspected defective batch.
- Documents designed, prepared, reviewed, and controlled, wherever applicable, shall suit these rules:
- Documents shall be approved, signed, and dated by appropriate and authorized persons.
- Documents shall specify the title, nature, and purpose. They shall be laid call in an orderly fashion and be easy to see. Reproduced documents shall be clear and legible. Documents shall be regularly reviewed and maintained so far. Any alteration made within the entry of a document shall be signed and dated.
- Records shall be completed at the time of operation so that each significant activity concerning the manufacturing of pharmaceutical products is traceable. Records and associated Standard Operating Procedures (SOP) shall be retained for a minimum of one year after the expiry date of the finished product.
- Data could also be recorded by electronic processing systems or other reliable means. However, Master Formulae and detailed operating procedures concerning the system in use shall even be available in a text to facilitate checking the accuracy of the records. Electronic processing methods handle wherever documentation and authorized persons shall enter or modify data within the computer. There shall be a record of modifications and deletions. Access shall be restricted by ‘passwords’ or other means, and therefore the results of the entry of critical data shall be independently checked. Batch records electronically stored shall be protected by an appropriate backup. During the amount of retention, all relevant data shall be readily available.