QA SOP 030 Document Review Committee [PDF]

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SHINIL Pharma Ltd. B K Bari, Mirzapur Gazipur. [



Standard Operating Procedure Title SOP for Document Review , Preparation, Update and Upgrade Document No. QA-SOP-30 Revision No. 00 Department Quality Assurance



Issue Date July 02, 2019 Effective Date July 02, 2019 Next Review Date July 01, 2021



Page 1 of 4



Distribution List 1. Archive Copy 2. Plant Manager 3. Quality Assurance Manager 4. Assistant Production Manager 5. Quality Control In-Charge 6. Product Development In-Charge 7. Warehouse In-Charge 1.0 Purpose To provide guidelines for review, preparation, update and upgrade and approval of all documents to lay down clear and concise procedures for effective implementation of quality system as per cGMP at SHINIL Pharma Ltd. 2.0 Scope This procedure is applicable for review, preparation, update and upgrade and approval of all documents for all the concerned department as per the distribution list. 3.0 Responsibility 3.1 Manager, Quality Assurance: Monitoring the system of compliance. 3.2 Function of Department Manager/In-charge: All Department Manager/In-charge will be responsible for department related functions as per written prescribed form and assign by superior which shall be transparent, unambiguous with document evidence. 4.0 Definition / Description: Not Applicable 5.0 Precaution: Not Applicable 6.0 Procedure Prepared By



Checked By



Approved By



Mustafigur Rahman Officer, Microbiologist



Md. Tuhin Kabir Senior Officer, Quality Control



Md. Awlad Hossain Manager- Quality Assurance



SHINIL Pharma Ltd. B K Bari, Mirzapur Gazipur. [



Standard Operating Procedure Title SOP for Document Review , Preparation, Update and Upgrade Document No. QA-SOP-30 Revision No. 00 Department Quality Assurance



Issue Date July 02, 2019 Effective Date July 02, 2019 Next Review Date July 01, 2021



Page 2 of 4



6.1 The requirement of a document for a given process, equipment or, policy shall be identified by the Document Review Committee and issue a letter to QAD/ respective department . 6.2 Any revision in document shall be initiated by concerned department through change control; When a document/ SOP undergoes revision, after the issue of the revised document/SOP, all the superseded controlled copies shall be withdrawn from the respective Department by Document Review Committee / QA within five working days and revised document shall be updated and upgraded, checked and approved. 6.3 The Document for each department except QA shall be updated and upgraded by respective department personnel, checked by the respective department manager/in-charge and approved by QA manager. 6.4 QA Documents shall be prepared by respective QA personnel and checked by Quality Compliance Officer/PD Officer and approved by QA Manager. 6.5 The final document will be approved by signing each page of the document in Blue Ink by the following individual: -Person who review, update and upgrade the Document -Person who Checked the updated and upgraded Document -Person who approved the updated and upgraded Document 6.6 For other format and instructions on document QA-SOP-01 shall be followed. 6.7 The document review committee Shall be as in “Appendix-A”. 7.0 Acceptance Criteria Not Applicable 8.0 Frequency Not Applicable 9.0 Reason for Revision Used on new format and text. 10.0 Appendices Appendix-A: Format for Document Review Committee Appendix-A: Format for Document Review Committee



Prepared By



Checked By



Approved By



Mustafigur Rahman Officer, Microbiologist



Md. Tuhin Kabir Senior Officer, Quality Control



Md. Awlad Hossain Manager- Quality Assurance



SHINIL Pharma Ltd. B K Bari, Mirzapur Gazipur. [



Standard Operating Procedure Title SOP for Document Review , Preparation, Update and Upgrade Document No. QA-SOP-30 Revision No. 00 Department Quality Assurance



Issue Date July 02, 2019 Effective Date July 02, 2019 Next Review Date July 01, 2021



Page 3 of 4



SHINIL Pharma Ltd. B K Bari, Mirzapur Gazipur. Document Review Committee Department



Production Quality Control Quality Assurance Product Development



Warehouse



Purpose



Name



Page No.: 1 of 1



Designation



Document Review By



Production Officer



Checked By



Deputy Manager, Production



Document Review By Checked By Document Review By Checked By Document Review By Checked By Document Review By



QC Officer QC In-charge QA Officer QC In-charge PD Officer PD In-charge Store Officer Deputy Manager, Production Manager, QA



Checked By All Document Approved By Prepared By: _______________



SOP No: QA-SOP-30



Sign & Date



Approved by: ______________ QA Manager



Revision History Revision No: 00 Page No : 1 of 1



Prepared By



Checked By



Approved By



Mustafigur Rahman Officer, Microbiologist



Md. Tuhin Kabir Senior Officer, Quality Control



Md. Awlad Hossain Manager- Quality Assurance



SHINIL Pharma Ltd. B K Bari, Mirzapur Gazipur. [



Standard Operating Procedure Title SOP for Document Review , Preparation, Update and Upgrade Document No. QA-SOP-30 Revision No. 00 Department Quality Assurance Sl. No 01



Date of Revision July 02, 2019



Revision No. 00



Issue Date July 02, 2019 Effective Date July 02, 2019 Next Review Date July 01, 2021 Page No. All



Page 4 of 4



Amendment Summary Before After ------------------------First Issue



Prepared By



Checked By



Approved By



Mustafigur Rahman Officer, Microbiologist



Md. Tuhin Kabir Senior Officer, Quality Control



Md. Awlad Hossain Manager- Quality Assurance