Follow
Objective: To describe the procedure for activities involved in the preparation, control, retrieval and archiving of quality related documents.
Scope: This procedure covers all the documents issued by Quality Assurance and it also includes documents related to regulatory, calibration, qualification and validation activities at (Company Name).
Responsibility
1 All employees of (Company Name).
2 Head of the department is responsible to ensure the compliance to the procedure.
Accountability: Head of Quality
Precautions: NA
Procedure
6.1 This procedure shall be applicable for all the new documents, which are prepared from the effective date of this document. The existing document shall be modified as per this procedure whenever due for periodic review or whenever they need to be revised on need basis.
6.2 The layout of the Quality Related documents
6.2.1 The layout of SOPs, calibration, validations, guidelines, QA policies, and qualification should be as per the respective templates.
6.2.2 Formats: The format can be designed according to the data that is to be entered. The form number along with revision number, concerned document reference number shall be placed at the bottom of the format.
6.2.3 Validation protocols and Reports: The format and contents are described in the procedure for validation protocols and Reports.
6.2.4 Quality related documents are essential documents, which establish the quality systems, and are required as per Good Manufacturing Practices (GMP).
6.2.5 Master Formula Record (MFR): The format and contents are described in the procedure for Preparation, approval, distribution, control & revision of MFR. (QA080)
6.2.6 Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR): The format and contents are described in the procedure for Preparation, approval, distribution, control & revision of Batch processing records. (QA081)
6.2.7 Specifications, Standard Test Procedures (STP) & General Test Procedures (GTP):
The format and contents are described in the procedure. (QC002)
6.3 Preparation, review and approval/ authorization of documents:
6.3.1 All documents (new or existing) are to be drafted by appropriately qualified personnel of the concerned department and submit to the head of the department along with properly filled ‘Document Change / Approval Request Form (Annexure – II) for checking. Before submission for checking, the responsible personnel shall initiate ‘DRAFT COPY’ stamped in blue ink at the right side top corner of the document.
6.3.2 The department Head shall circulate the draft document to concerned section Heads for checking. All the comments / inputs shall be written directly on the draft, signed and dated by the respective persons.
6.3.4 After the draft document has been commented on by all the concerned Heads, a final checking /review is carried out by the QA department.
6.3.5 If there are changes, a further document is prepared and circulated until the final draft is agreed.
6.3.6 After the review, if there are no changes, the draft document shall be signed as approved by Head of Quality and sent to the concerned department Heads for finalization.
6.3.7 Concerned department then shall prepare the final copy and assign sequential number (in case of new documents) as per document numbering procedure (QA003). In case of existing documents, only the version number will be changed.
6.3.8 The final document shall then be signed by the responsible staff. All the draft copies are to be destroyed subsequently.
6.3.9 Concerned department Head shall send the approved master copy to QA for distribution or Issuance of controlled copies.
6.3.10 After receiving the approved master document, QA manager shall put the effective date in the ‘Document Change /Approval request form’ and sing with date.
6.3.11 QA shall issue the controlled copy of documents to concerned departments as per step No. 6.9.
6.4 Standard Operating Procedures
6.4.1 Follow the step No. 6.3.1 to 6.3.11.
6.4.2 Sufficient time is given between issue date and effective date to enable training of concerned people.
6.5 Master Formula Records
6.5.1 Master Formula Record for each product and batch size shall be prepared by Research & Development department.
6.5.2 MFR shall be drafted by Research & Development by using relevant template.
6.5.3 Draft MFR shall be stamped ‘DRAFT COPY” in blue ink at right side top corner of the document.
6.5.4 Draft MFR shall be sent for review to QC Manager, Production Manager and QA Manager.
6.5.5 Research & Development Head shall prepare the final copy and assign sequential number as per document numbering procedure (QA003) and get the signatures of the responsible staff.
6.5.6 Research & Development Head shall send duly signed master copy of MFR to QA for distribution or Issuance of controlled copies.
6.5.7 QA shall issue the controlled copy of documents to concerned departments as perstep No. 6.9
6.6 Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs)
6.6.1 After finalization of MFR, Batch Manufacturing Record and Batch Packaging Record shall be prepared by Research & Development department.
6.6.2 BMR & BPR shall be drafted by Research & Development by using relevant template.
6.6.3 Draft BMR & BPR shall be stamped ‘DRAFT COPY” in blue ink at right side top corner of the document.
6.6.4 Draft BMR & BPR shall be sent for review to QC Manager, Production Manager and QA Manager.
6.6.5 Research & Development shall prepare the final copy and assign sequential number as per document numbering procedure (QA003) and get the signatures of the responsible staff.
6.6.6 Research & Development shall send duly signed master copy of BMR & BPR to QA for distribution or Issuance of controlled copies.
6.6.7 QA shall issue the controlled copy of documents to concerned departments as perstep No. 6.9
6.7 Specifications, Standard Test Procedures (STPs) and General Test Procedures (GTPs)
6.7.1 Specification: A list of tests, references to analytical procedures and appropriate acceptance criteria that can be numerical limits, ranges or other criteria to which a material must conform to be considered acceptable for intended use.
6.7.2 Test Procedure: Analytical procedures that are to be followed against any test described in specification.
6.7.3 Each material must have unique specifications and test procedures. The test procedure shall give the details of methods to be carried out against each test parameter defined in the specifications.
6.7.4 QC shall prepare all specifications, STPs and GTPs by using relevant template as per Procedure. (QC002)
6.7.5 Draft Specifications, Standard Test Procedures & General Test Procedures shall be sent for review to QC Manager, Research & Development Manager and QA Manager.
6.7.6 QC shall prepare final copy of documents and assign sequential number to all specifications, GTPs and STPs as per document numbering procedure (QA003)
6.7.7 The specifications, GTPs and STPs shall be prepared, checked and approved by persons as defined in the responsibility.
6.7.8 QC shall send the duly approved master copy to QA for distribution or issuance of controlled copies.
6.7.9 QA shall issue the controlled copy of documents to concerned departments as perstep No. 6.9
6.8 Qualification and Validation Documents
6.8.1 QA/ Validation Department shall prepare the Qualification documents by using relevant templates.
6.8.2 After finalization of BMR and BPR QA / Validation department shall be prepared validation documents by using relevant template.
6.8.3 Draft Validation documents shall be stamped ‘DRAFT COPY” in blue ink at right side top corner of the document.
6.8.4 Draft validation documents shall be sent for review to QC Manager, Production Manager, Research & Development Manager, Engineering Manager and QA Manager.
6.8.5 Validation/QA department shall prepare the final copy and assign sequential number as per document numbering procedure (QA003) and get the signatures of the responsible staff.
6.8.6 QA shall issue the controlled copy of documents to concerned departments as perstep No. 6.9
6.9 Distribution or Issuance of Controlled and Uncontrolled documents
6.9.1 All the GMP documents related to the manufacturing plant will be issued by QA. The Controlled copies of documents shall be made by QA by photocopying the master copy. All the copies shall be stamped in the right side bottom of all the pages with Red ink bearing following details.
• Serial No. of Copy
• Date of Issuance
• Sign of QA person
6.9.2 If an additional copy of document is required by any department / regulatory for non-operational use then QA dept. shall issue an additional copy only after written approval from Head of Quality. Such requests shall be obtained through the Request Form as per Annexure – III.
All photocopied documents shall be stamped with blue ink on all the pages as “UNCONTROLLED COPY” across the text and shall be signed by the QA Manager/Officer under the stamp.
6.9.3. The controlled copies of new documents shall be distributed to the concerned departments and sufficient time should be given before the effective date of the document to enable training of the concerned people and the ‘Document control register’ shall be maintained by QA department as per FRM No.: FQA/078 (Annexure – V).
6.9.4 All formats shall be controlled by QA. The required number of working format shall be copied from control copy by respective department head or his nominee and reconciliation of copied format shall be done by respective department head or his nominee as per FRM No. : FQA/101 (Annexure-VI).
6.10 Revision of existing documents
6.10.1 Documents such as SOPs, MFR, BMR, BPR etc which requires revision due to change control shall be revised by concerned department.
6.10.2 Initiation of new document by any department shall follow the approval procedure as per Annexure – II.
6.10.3 Revised documents shall be given sequential revision No. and controlled by QA.
6.10.4 Documents undergoing change due to regulatory requirements / audit compliance shall also be revised through proper change control by the concerned department.
6.10.5 QA shall distribute the controlled copies of revised documents to concerned departments as per step No. 6.9.
6.11 Retrieval or Recall of Obsolete Controlled copies and Superseding of Obsolete Master documents
6.11.1 When the document has been revised following a change request, the older version must be superseded.
6.11.2 Obsolete versions of documents are retrieved and reconciled and entries are made in ‘Distribution record’ (FQA/003).
6.11.3 All retrieved controlled copies of documents shall be destroyed immediately by shredding & recorded.
6.11.4 The Master Copies of the superseded documents along with document change /approval request form shall be archived in the QA department stamped as “OBSOLETE FOR REFERENCE ONLY” in Blue Ink maintaining the a log register (Annexure – VII).
6.12 Retention
6.12.1 The Retention period is based on the necessities resulting from the statutory bodies or any contractual obligations. The Retention period of quality related documents is mentioned in Annexure – IV.
6.12.2 All quality related documents should be stored securely and safely with controlled access, protected from damage and mutilation. The storage areas and access restriction to the retention of these documents are mentioned in Annexure – I.
6.12.3 The documents related to legal proceeding should be securely kept till the legal proceeding are over.
6.12.4 All documents relevant to quality of the in-house manufactured products must be included in the documents archiving system.
6.12.5 QA shall maintain all the Master documents.
6.12.6 Responsible QA officer shall maintain a log register for taking & re-archiving of documents from QA Documentation Room (Annexure – VIII).
6.12.7 A separate log register shall be maintained by responsible QA officer for taking & re-archiving of documents from QA Archive Room (Annexure – VIII).
6.12.8 A log register shall be maintained by responsible QA officer to archive the Batch Production Records (Annexure – IX).
6.13 Destruction
6.13.1 QA department shall destroy the documents after the retention period is over and maintain a record of the same.
6.13.2 The destruction may be performed by shredding, cutting, tearing, to make the documents non-usable.
6.13.3 A file note (FRM No.: FQA/144) will be prepared. A list of documents with sufficient informations like document number, effective date, review date etc. (or manufacturing date, expiry date, batch number or lot number of the materials or products etc.) will be attached as an annexure in the file note. Destruction approval will be given by Manufacturing Head and Quality Head.
6.13.4 Documents relating to any legal proceeding shall not be destroyed till the legal proceeding is declared closed.
6.13.5 Documents for products supplying to highly regulated markets, the retention time of the document will be 20 years and then after the documents are to be evaluated by Quality Head in communication with regulatory department before destruction.
