REPROCESSING AND REWORKING OF SEMI-FINISHED AND FINISHED PRODUCTS
REPROCESSING AND REWORKING SEMI-FINISHED AND FINISHED PRODUCTS PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
SOP ON SOP
SOP ON SOP PURPOSE: To describe a procedure for preparation, review, approval, revision, and control of Standard Operating Procedures and General Test Procedures. SCOPE: Applicable to all Standard Operating Procedures and General Test Procedures. RESPONSIBILITY: Author/ Initiator of respective section shall be responsible for preparation or revision of SOP & GTP. Shall be responsible for sending document…
Annexure – I for Anual product quality Review
Annual Product Quality Review Report Product Description Product Name: Generic Name: Label Claim: Strength: Packaging Types Available: M.F. Nos. Batch sizes available: Markets Shelf Life Indications Time Period Covered for APR ___________________ to ______________________ Batches Manufactured: Batch Number _____________ to _____________…
PREPARATION AND REVIEW PROCEDURE OF ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)
PREPARATION AND REVIEW PROCEDURE OF ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)
HANDLING, MANAGEMENT AND INVESTIGATION OF DEVIATION
HANDLING, MANAGEMENT AND INVESTIGATION OF DEVIATION SOP for Product Process Qualification(PPQ) /Process Validation in Pharma
Cleaning Policy of Area & Equipment SOP
Cleaning Policy of Area & Equipment SOP Objective: To lay down the procedure for the Cleaning Policy of the Area & Equipment. Scope: This Standard Operating Procedure applies to all the departments at the formulation plant. Responsibility : The production Operator/ Technician shall be responsible for cleaning. Production & QA Officer/ Executive shall be responsible for the…
SOP of Operating Procedure for Tablet Hardness Tester
SOP of Operating Procedure for Tablet Hardness Tester Objective:To lay down the Operating procedure for Tablet Hardness Tester. Scope:This Standard Operating Procedure is applicable for formulation plant of (Write Pharmaceutical Company Name with Location). Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this SOP. Production Supervisor / Officer…
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Good Documentation Practices SOP
Objective of Good Documentation Practices : To lay down the procedure for Good Documentation Practices in the facility. Scope: This standard operating procedure applies to all departments involved in documentation activities throughout the facility of the Pharmaceutical Company. Responsibility: All employees of Quality Assurance, Quality Control, Production, Warehouse, Engineering, Personnel, and administration must follow this SOP. Accountability:…
sop of Pharmaceutical Inspection Co-Operation scheme (PICS)
sop of Pharmaceutical Inspection Co-Operation scheme (PICS) PIC/S GMP Guide (Last updated by PIC/S Secretariat on 12 February 2016) Documents for industry (PIC/S GMP Guide) PIC/S GMP GUIDE PE 009-12 Download PIC/S GMP GUIDE (INTRODUCTION) PE 009-12 Download PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) PE 009-12 Download PIC/S GMP GUIDE (PART…
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Question & Answer on ICH For Pharma
Question & Answer on ICH For Pharma Question and Answer on ICH Q7 Question and Answer on Q8 ,Q9 and Q10 For More Pharma Updates Visit –https://pharmaguidances.com
Management ,Materials and Safety as per WHO in Pharma
WHO in Pharma Management and Infrastructure Quality health services depend on effective health management and strong infrastructure. The World Health Organization (WHO) is the world’s leading authority on public health, providing guidelines and recommendations to countries around the world to improve health governance and infrastructure. Management: Leadership and Governance: The importance of strong leadership and…
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WHO GUIDLINE FOR PHARMA PRODUCTION
WHO GUIDLINE FOR PHARMA PRODUCTION WHO good manufacturing practices WHO good manufacturing practices for pharmaceutical products: main principles(Annex 2, WHO Technical Report Series 986,2014) Active pharmaceutical ingredients (bulk drug substances) (Annex 2, WHO Technical Report Series 957,2010) Pharmaceutical excipients (Annex 5, WHO Technical Report Series 885,1999) WHO good manufacturing practices for sterile pharmaceutical products (Annex 6, WHO Technical…
sop on Handling of FBD bag
sop on Handling of FBD bag Objective:To lay down a procedure for handling of FBD bag. Scope:This SOP is applicable receipt, issuance, usage cleaning and retrieval of F.B.D Bag to the formulation plant of (Pharmaceutical Company Name). Responsibility Operator/ Technician of production shall be responsible for issuance, usage, cleaning and retrieval of FBD bag. Production…
SOP On Product Change Over during Manufacturing
SOP On Product Change Over during Manufacturing Objective: To lay down a procedure for the product Change Over during Manufacturing. Scope: This SOP is applicable for the product change over during manufacturing of product in the formulation. Responsibility Production Operator/ Technician shall be responsible for operation of the machine. Production/IPQA Officer/ Executive shall be responsible…
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sop of Rejection of Packaging Materials
SOP of Rejection of Packaging Materials Objective:To lay down a procedure for handling of obsolete / rejected printed and unprinted packaging materials and line rejections. Scope:This procedure is applicable to packing materials store for formulation plant of (Pharmaceutical Company Name). Responsibility: Packing material store personnel shall be responsible to follow the procedure mentioned in this…
sop of Reconciliation of raw materials & packaging materials
SOP of Reconciliation of raw materials & packaging materials Objective:To provide a procedure for reconciliation of raw materials & packaging materials. Scope:This SOP is applicable to all raw material & packaging material available in the warehouse of formulation plant at (Pharmaceutical Company Name). Responsibility:Raw Material & Packing Material Store personnel shall be responsible for reconciliation…
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SOP on Receiving and storages of finished goods from production area
SOP on Receiving and storages of finished goods from production area Objective of SOP: To lay down a procedure for receiving and storages of finished goods (Oral & Injectable) from production area. Scope: This SOP is applicable for receiving & storages of finished goods (Oral & Injectable) in warehouse area of formulation plant of (Pharmaceutical…
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sop of Receive the materials returned from production department
SOP of Receive the materials returned from production department Objective: To lay down a procedure to receive the materials returned from production department. Scope: This SOP is applicable to all raw and packing materials returned from production department to Warehouse of the formulation plant of (Pharmaceutical Company Name). Responsibility: Concerned Store personnel shall be responsible…
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sop of Operation of dispensing booth
sop of Operation of dispensing booth Objective:To lay down a procedure for operation of dispensing booth. Scope:This procedure is applicable to the Raw material Store at (Pharmaceutical Company Name). Responsibility: Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP. Raw material Store in-charge shall be responsible for implementation of…
sop on Issue of additional Raw and Packaging materials
sop on Issue of additional Raw and Packaging materials Objective:To lay down a procedure for issuing additional raw and packing material to the Production Department. Scope:This SOP is applicable for issuing additional raw and packing material to the Production Department at (Pharmaceutical Company Name). Responsibility:Warehouse personnel shall be responsible for issuing additional raw and packing…
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