SOP for Documentation in Pharmaceutical Industry | Good Documentation Practices SOP |
- Documentation SOP covers below points:
- Major Documents Category
- Document Creation
- Document Distribution
- Document Uses
- Document Control
- Document Revision and Retention
- Destruction of old records
1.0 OBJECTIVE :
- To describe a procedure for Creation, Distribution, Use, Revision and Retention of Documents related to all activities with the potential to impact product quality.
2.0 SCOPE :
- This procedure is applicable to all authorized physical documents in compliances with Good Documentation Practice.
3.0 RESPONSIBILITY :
- Chemist/ Officer and above
4.0 ACCOUNTABILITY:
- Q.A. Head
5.0 PROCEDURE :
5.1 Documentation is an essential part of Quality Assurance System and must exist for all aspects of GMP.
Major documents are grouped into following categories,
- A. Commitment Documents, which includes Registration Documents, Validation Master Plan, Site Master File, Contracts/ Agreements etc.
- B. Specifications, which includes Master Formula Record, Dossiers, Product Standards, Art work for Labels, Design Specification of Facilities and its Operating Instructions, User/ design requirement specifications for computer.
- C. Instructions which includes Standard Operating Procedures, Cleaning and Sanitizatition Schedules and Instructions, Validation Protocols, Stability Plans, Annual Product Quality Review, Analytical Methods, Maintenance Procedures, Calibration, training etc.
- D. Others records including Inventory and Material Usage, Batch Processing Records, Analytical Testing/ Certificates of Analysis, Equipment Logs, Cleaning Validation, Stability, Complaints, Organization Charts with Job Descriptions, Recalls, Deviation, Change Control etc.
5.2 Creation, Distribution, Use and Control:
- Create all documents in simple language.
- Enter date as Day/Month/Year i.e. DD.MM.YYYY.
- Enter time in 24 hours format.
- Use black ink ball pen by QA and blue ink ball pen by Production for entering of any data into documents.
- Never use scrap paper while creating any of the documents.
- Make online entries in the batch records, log books and all other related documents along with the signature, initials, date wherever applicable.
- Enter current date in any of the documents.
- Strike out incorrect data, in case of any wrong entry made in document, enter the correct data near correction made and write explanation, if required.
- Do not overwrite any data and do not leave blank in-process sheet, batch manufacturing records, log books and laboratory note books.
- Enter information in sequential and stepwise manner.
- Do not use corrective fluid or erasable pens for any corrections.
- Authorize all the documentation properly before release for circulation.
- Put a stamp of ‘MASTER COPY’ with red ink on top left side of the each page, while making master copy.
- Remove all superseded and redundant documentation.
- Keep only one master copy with ‘OBSOLETE’ stamp in red ink, in centre of every page.
- Do not make photocopy of official document without authorization of Head QA and above at any circumstances.
- Issue and use only authorized formats of standard operating procedure and other process documents which are used for working, filling and use, by the department, after putting stamp of ‘WORKING COPY –(Green) at the bottom right corner of each page by QA.
- Issue authorized documents for display after putting stamp of ‘CONTROLLED COPY’ in blue ink on bottom right corner of each page.
- Recover superseded documents directly from the relevant departments before issuing revised SOP/ other document in case of revision.
- Place authorized master documents in a secure place.
- Destroy by threading or authorized procedure, all extra copies of the recovered, except master copy of superseded documents. Witness such destruction and record in the register.
- Retain the master copies of all relevant formats in QA Department which are stamped with ‘MASTER COPY’ in red ink.
- Distribute the formats to relevant departments by making photocopies which are stamped with ‘WORKING COPY’ stamp in green ink.
5.3 Revision and Retention:
- Review Standard Operating Procedures on or before 3 years as per review date mentioned on the document.
- Give new revision number, effective date and description of change in space provided, in case of revision of SOP.
- Make obsolete previous SOP by stamping it as ‘OBSOLETE’ in red ink.
- Destroy all the controlled copies given to various departments of OBSOLETE SOP and maintain the record of destruction.
- Circulate the controlled copies of revised document.
- Mark the stamp of ‘UNCONTROLLED COPY’ in blue ink on the copies of documents, which are given to outsider of company like FDA, factory inspector etc.
- Retain the all batch related records like BMR, BPR up to the one year after the expiry of the product.
- Retain all SOP (obsolete copies) for 5 years.
- Retain records like Raw Material, Packing Material & Finished Product Analytical Data, Change Control Forms, Deviation Forms, Destruction Records, Complaint Records, Self Inspection Records, Vendor Audit Records, Incidence Reports, all Calibration Records, Out of Specification Records, Cleaning Records, Log Books/Sheets & Registers, Preventive Maintenance Records, Material Stock Records, other records relating to any process of any department for 5 years.
- Retain training records of employees for 3 years after relieving of employee.
- Retain the records which are original or authenticated copies.
- Keep the documents of the samples, which are under legal proceedings, till the legal matter is resolved or as stated above which is later.
- Keep Qualification / Validation documents, Annual Product Quality Review, Specifications permanently.
- Maintain all BMR, BPR into shippers duly arranged in racks as per manufacturing date of the product, in the room provided. Label those shippers for Month and Year. The room is locked and the keys of the room are kept with QA head.
5.4 Destruction of old records:
- Remove and check the batch related records by QA person, on completion of retention period.
- Keep the batch related records of the batch involved in legal matter, any complaint, or FDA inquiry, in safe place, till the specific matter is resolved.
- Destroy the records which are kept for destruction by using suitable method.
- Keep record of destruction by making necessary entries in Document Destruction Record.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| GMP | Good Manufacturing Practices |
| FDA | Food and Drug Administration |
7.0 ANNEXURES:
Nil
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
