OBJECTIVE:

• To describe the systematic procedure for preparation, review, approval, issuance, revision, retrieval, archival, retention, and destruction of all controlled documents.

• To ensure that only current, approved, and authorized versions of documents are available for use within the facility.

SCOPE:

• This SOP applies to all Quality Management System (QMS) documents generated and maintained at company, including but not limited to:
  • • Standard Operating Procedures (SOPs)
    • Batch Manufacturing/Packaging Records (BMR/BPR)
    • Specifications,
    • Test Methods,
    • Protocols, Reports
    • Validation and Qualification documents
    • Logbooks, Forms, Checklists
    • Controlled records in hard or electronic form
• Excludes regulatory submissions and third-party documents not owned by Company.

RESPONSIBILITIES:

User Department

• • • Prepare new or revised draft documents.
    • Ensure correctness, legibility, and completeness.
    • Withdraw and return obsolete copies to QA.
    • Maintain records of controlled copy use.

Designee Quality Assurance (QA)

• • Verify format, numbering, and compliance with QMS template.
  • Assign document number and version.
  • Approve, issue, distribute, archive, and control master and controlled copies.
  • Maintain the Document Distribution Log, Master List, and Obsolete Document Log.
  • Ensure obsolete versions are promptly removed from all points of use.
  • Control electronic copies and backup.
  • Maintain retention and destruction records.

Department Head / QA Head

• • Approve documents before issue.
  • Ensure periodic review and data integrity compliance.

All Employees

• • Use only current approved documents.
  • Ensure entries are signed, dated, and compliant with ALCOA+ principles.

DEFINATIONS:

• Master Document: Approved, original version maintained by Quality Assurance.
• Controlled Copy: Copy of the master document issued for routine use under Quality Assurance control.
•  Obsolete Document: A superseded document withdrawn from use.
•  Change Control Form (CCF): Authorized form used to initiate and track document revisions.
•  ALCOA+: Data integrity principles – Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available.

PROCEDURE:

Initiation and Drafting:

• The need for a new document or a revision shall be initiated by the User Department through a Change Control Form.
• The author shall draft the document using the approved template and shall ensure that the content is complete, unambiguous, technically accurate, and consistent with current regulations and site procedures.
• The draft shall clearly identify impacted procedures, records, systems, and training requirements.

Review:

• The Department Head shall review the draft for accuracy, clarity, and practicality, and shall confirm that cross-functional inputs have been obtained where required.
•  QA shall review the draft for format and compliance with Good Documentation Practices (GDP), numbering, version control, and data integrity requirements.
•  Where applicable, Quality Control (QC), Regulatory Affairs (RA), Production, Engineering, and Environment Health and Safety (EHS), Pharmacovigilance (PV), Warehouse (WH), Human Resources (HR) and Administration shall conduct technical reviews of the sections relevant to their functions.

 Approval and Effective Date:

• The document shall be approved, signed, and dated by the required authorities in the sequence defined on the signature page.
•  The QA Head shall assign the effective date. The effective date shall normally allow adequate time for communication and training; urgent effectiveness may be granted with documented justification and risk assessment.
•  QA shall stamp the Master Document as “MASTER COPY” and shall place it under controlled storage.

Issuance and Distribution:

• QA shall issue controlled copies only after final approval and effective date assignment.
•  QA shall stamp the first page of each controlled copy as “CONTROLLED COPY – ISSUED BY/DATE” and shall mark subsequent pages “CONTROLLED COPY.”
•  QA shall record each issuance in the Document Distribution Log, including document number, title, version, recipient department, copy identification, date, and the issuer’s signature.
•  User Departments shall not reproduce controlled copies without written authorization from QA.

 Use and Good Documentation Practices:

• Users shall ensure that only current, controlled documents are present at points of use.
•  Entries on records shall be made at the time of activity, in indelible blue ink, signed with full signature or approved initials, and dated in the defined format (DD-MMM-YYYY unless otherwise specified).
•  Corrections shall be made by striking a single line through the error, entering the correct data, adding initials, date, and a brief reason if not obvious.
• Correction fluid or erasures shall be prohibited.
•  Photocopies of blank records for operational use shall be treated as controlled forms and shall be numbered or otherwise tracked as defined by QA.

 Revision Control:

• Revisions shall be initiated via Change Control. The CCF shall describe the reason for change, impacted documents, risk assessment, training needs, and implementation plan.
•  Each approved revision shall increment the version number sequentially.
•  QA shall update the Master Document Register and shall publish the revised controlled copies. QA shall simultaneously retrieve the obsolete copies from all points of use.

 Retrieval and Obsolescence:

• When a document is revised or cancelled, QA shall retrieve all obsolete controlled copies from user areas without delay.
•  QA shall mark Master copies of superseded versions as “OBSOLETE – FOR REFERENCE ONLY” and shall archive them in accordance with retention rules.
•  QA shall maintain an Obsolete/Destruction Log to record withdrawals and the final disposition of obsolete documents and records.

 Archival and Retention:

• QA shall store Master Documents and archived records in a secure, access-controlled, and environmentally suitable area that protects against loss, damage, and unauthorized access.
•  Electronic repositories shall be validated, access-controlled, and backed up at defined intervals; restoration tests shall be performed at defined frequencies.
•  Unless otherwise mandated by regulation, the minimum retention periods shall apply as per the format F/QA022/001 – 00 or if the documents not covered in the format, The frequency of retention shall be followed as per mentioned in the respected SOP.

 Destruction:

• Upon expiry of the defined retention period, QA shall authorize destruction in writing.
•  Paper records shall be destroyed by secure shredding or an equivalent method that prevents reconstruction.
•  QA shall record the document title, number, version, retention expiry date, destruction method, destruction date, and authorizing signatures in the Destruction Log.

 Training and Implementation:

• QA shall ensure that all impacted personnel are trained on newly approved documents prior to operational use when the change impacts execution.
• Training shall be documented with trainee names, trainer name, date, document number and version, and assessment or acknowledgment where applicable.
• The effectiveness of training and implementation shall be verified through routine line checks, internal audits, or targeted reviews.

Data Integrity:

• All entries and approvals, whether on paper or within an electronic system, shall be attributable to an identified individual.
•  Electronic systems shall maintain audit trails that capture creation, modification, deletion, user identity, timestamps, and reasons where required.
• Access rights shall be role-based and periodically reviewed.
•  Backups shall be performed and tested at defined frequencies, and restoration procedures shall be documented and periodically verified.
•  Electronic signatures, where used, shall be unique to the signer, controlled, and legally equivalent to handwritten signatures as per validated system controls.

 Deviation:

• Any deviation from this SOP shall be documented, investigated, and approved in accordance with the Deviation and CAPA procedures.
• Temporary arrangements for urgent document effectiveness shall be justified by risk assessment and approved by QA.

REFERENCE:

• EU GMP Part I – Chapter 4: Documentation
• EU GMP Annex 11: Computerized Systems
• WHO TRS 957 Annex 4 – Good Documentation Practices

RECORDS:

 REVISION HISTORY: