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 is applicable to all the departments at the formulation plant. Responsibility The production Operator/ Technician shall be responsible for cleaning. Production & QA …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »SOP for Issuance of Raw material
SOP for Issuance of Raw material Raw materials are the foundation of pharmaceutical manufacturing. These essential components are sourced from various suppliers and play a crucial role in the quality and efficacy of the final product. Ensuring the purity and integrity of raw materials is vital to meet regulatory standards …
Read More »SOP of Issuance of packaging materials
SOP of Issuance of packaging materials Objective:To lay down a procedure for issuance of packaging materials and transfer of issued materials from warehouse to production area. Scope:This procedure is applicable for issuance of packaging materials and transfer of issued materials from warehouse to production area of the formulation plant at …
Read More »SOP of Handling of Obsolete Rejected and on line rejections of raw materials
SOP of Handling of Obsolete Rejected and on line rejections of raw materials Objective: To lay down a procedure for handling of Obsolete / Rejected and on line rejections of raw materials. Scope: This procedure is applicable to warehouse of formulation plant for Pharmaceutical Company Name). Responsibility:Store personnel shall be responsible …
Read More »SOP of Dispensing of Solvent Liquid Materials
SOP of Dispensing of Solvent Liquid Materials To lay down the procedure for dispensing of solvent / liquid materials. Scope This SOP is applicable for dispensing of solvent / liquid materials in warehouse at (Pharmaceutical Company Name). Responsibility Raw material Store personnel shall be responsible to follow the procedure mentioned …
Read More »Dispatch of Finished Goods
Dispatch of Finished Goods Objective of this SOP – Dispatch of Finished Goods: To lay down a procedure for dispatching finished goods from the finished goods warehouse. Scope: This SOP is applicable for the finished goods warehouse of the formulation plant Responsibility: Finished Goods Store personnel shall be responsible to …
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