1.0 Purpose
1.1 To describe the procedure for the control, Initiation, revision, review and approval of all document.
2.0 Scope
2.1 This Sop is applicable for all document such as Standard Operating Procedure (SOP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Standard Test Procedure (STP), Logbooks, Qualification and Validation Documents, etc. of "NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Originator is responsible for creating new documents or revising current approved documents.
3.2
Reviewers are responsible for
assuring the accuracy, technical content and completeness of the document.
3.3 Quality Assurance is responsible for:
3.3.1 Assigning document numbers and assuring new or revised documents have been assigned the correct number and/or revision level.
3.3.2 Maintain the Master Document File. (MDF)
4.0 Abbreviations and Definitions
4.1 Document : An official paper or book that gives information about something or that can be used as evidence of proof of something or that instruct activities.
4.2 Record : A written account of something that is kept so that it can be looked at and used in the future.
4.3 QA : Quality Assurance
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Not Appreciable
7.0 Procedure
7.1 Document Initiation
7.1.1 Prior to drafting a new or revising an existing document, obtain a Document number from QA. This ensures that another employee is not concurrently draft or revises the same document.
7.1.2 Enter the assigned document number in respective logbook.
7.1.3 For drafting a new document, reference the appropriate SOP of the document type for standardized format and content requirements.
7.1.4 Write the new document with clarity, creating a document that is specific and informative yet flexible and practical.
7.1.5 Determine a clear, concise title for the document. Contact appropriate personnel if assistance in naming the document is needed. In the header or footer space of each page, place the document number, the revision level (e.g. “revision no. 00” for new document) and pagination.
7.1.6 Label the draft document with the word “DRAFT”.
7.1.7 Compile and attach data to the draft document to support the contents of the document, if applicable.
7.2 Document Revision
7.2.1 Anyone who determines that a document requires modification, submit a ‘Document Change Request’ form and a draft version of the document to QA Department.
7.2.2 For documents being revised, highlight or “red-line” the proposed changes on a hard copy of the current approved document to assist those reviewing the changes. Include a “red-line” change to the revision level as well. Mark the “red-line” document with the word “DRAFT”.
7.2.3 For revisions to exiting approved documents, changes can be made on the document electronically by requesting a working copy from QA on disk or by e-mail, if applicable. The electronic copy will not show the approval signatures and the approval date.
7.2.4 If the revision includes a specification change, attach all supporting data with draft document for review or reference the file that contains the supporting data.
7.2.5 All documents require review/approval by QA. The QA review assures that the document meets Documentation requirements, that it does not conflict with existing procedures and any applicable Regulatory requirements.
7.3 Document Change Request (DCR) Completion
7.3.1 Complete the Document Change Request (DCR) form as follows.
7.3.2 Enter the document title, document number, current revision level and document type.
7.3.3 Specifically describe the change(s), give a brief statement regarding the reason for the change(s) and list the documents affected by the change.
7.3.4 Make changes to affected related documents and attach the related documents to the DCR form. For assistance in determining affected related documents, contact the department supervisor and QA.
7.3.5 Assign individual DCR to each document drafted or revised. The exception to this would be in the case where a change impacts multiple documents.
7.3.6 After a document has been approved, QA will log it into Master Document Index.
7.4 Assignment of Document Number and Revision Levels
7.4.1 Assign a document identification number and revision level as per QA ‘Document Numbering System’.
7.4.2 After a document has been approved, QA will log it into Master Document Index.
7.5 Administrative Changes
7.5.1 Make insignificant changes, referred to as “administrative changes”, any time without a formal process. Administrative changes include the correction of topographical errors, forma errors and spelling errors. Use the following procedure for making administrative changes and corrections.
7.5.1.1 “Red-line the correction into the document.
7.5.1.2 Obtain the review and approval of the “red-lined” correction from QA Head.
7.5.1.3 Request QA to incorporate the correction into the document and do not change the revision level.
7.5.1.4 File the approved document in the Master Document File.
7.5.1.5 Distribute copies of the “revised” document as appropriate.
7.6 Effective Date
7.6.1 The effective date of a new or revised document is the date of final approval or date after the final Approval unless:
7.6.1.1 A Discrepancy Report exists to approve the document for use prior to completing final approval.
7.6.1.2 A request has been made to delay the effective date in order to complete an In-process job.
7.6.1.3 A product is awaiting approval by regulatory authority.
7.7 Obsolete Document
7.7.1 Obsolete all documents using specific process.
7.7.2 Do not reassign document number from an obsolete document.
7.8 Document Filling and Distribution
7.8.1 File, maintain and control by document number all original versions of approved documents, all Originals of prior revisions of the document and supporting data in Master Document File located in the QA Department.
7.8.1.1 Original documents are not distributed for use. Limit access to original documents to authorized personnel only. Keep copies of the original versions (or make copy when needed) for distribution.
7.8.2 After the new revised version of a document is filled, inform appropriate personnel of current revision changes, new documents and obsolete documents.
7.9 Document Archiving and Disposal
7.9.1 Refer to Sop for “Retention and disposal of Documents/Records, for the retention time of Documents and records and their disposal procedure.
7.10 Reviewing, archiving and distribution of all Quality Control documents including Specifications, Method of Analysis, Test Record Sheet to be controlled by Quality Control Department.
8.0 Reference Document
8.1 WHO GMP Guideline; TRS-986, Annex-2
8.2 In house
9.0 Annexure
9.1 Annexure-I : Document Initiation Request Form
9.2 Annexure-II : Document Change Request Form
10.0 Revision History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head of Quality Assurance or his nominee give the training of all Officer and Manager .
