USFDA WARNING LETTER 2015 (Finished Pharmaceuticals) in Pharma Advanced Physician Solutions, Inc. 11/3/15 Ionia Pharmacy 12/22/15 Hospira Spa 3/31/15 Triangle Compounding 11/2/15 Micro Labs Limited 1/9/15 Mylan Laboratories Limited 8/6/15 Sun Pharmaceutical Industries Ltd. 12/17/15 Hieber’s Pharmacy 9/29/15 Pan Drugs Ltd. 9/2/15 Jaychem Industries Ltd 9/4/15 Walgreens Infusion Services 8/27/15 …
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 »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 Raw & Packaging Materials under Re-Test due
SOP of Handling of Raw & Packaging Materials under Re-Test due Objective:To lay down a procedure for Handling of Raw & Packaging Materials under Re-Test due. Scope:This SOP is applicable to all raw & packaging materials under retest due in warehouse at (Pharmaceutical Company Name). Responsibility: Concerned Store personnel shall …
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 …
Read More »SOP of Receiving the raw materials and packaging materials
SOP of Receiving the raw materials and packaging materials Objective: To lay down a procedure for receiving the raw materials and packaging materials. Scope: This SOP is applicable for the receipt of Raw and Packing material to the warehouse of the formulation plant at (Pharmaceutical Company Name). Responsibility: Raw Material …
Read More »DGFT guidelines for Barcoding as per GS1 Standards Pharmaceuticals
DGFT guidelines for Barcoding For More Pharma Updates Visit https://pharmaguidances.com as per GS1 Standards Pharmaceutical For More Pharma Updates Visit –https://pharmaguidances.com
Read More »Pharma Quality Assurance Question & Answer
Pharma Quality Assurance Question & Answer 1.Question: What is the SOP? Answer: SOP is abbreviation of Standard Operating Procedure SOP is a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently. 2.Question: What is …
Read More »HVAC SYSTEM RE-QUALIFICATION PROTOCOL PHARMA
HVAC SYSTEM RE-QUALIFICATION PROTOCOL PHARMA TABLE OF CONTENT Approval sheet Objective Scope Responsibility Qualification Team Abbreviation and definition Prerequisites Precautions and instruction (Health, Safety and Environment) Air velocity, Air volume and air Change Per hour measurement Procedure for HEPA Filter integrity Procedure for Temperature, Relative Humidity and differential Pressure Measurement …
Read More »SOP FOR TEMPLATE FOR PROCESS VALIDATION PROTOCOL IN PHARMA
SOP FOR TEMPLATE FOR PROCESS VALIDATION PROTOCOL IN PHARMA CONTENTS of PROCESS VALIDATION PROTOCOL Protocol Approval Sheet Objective Scope Responsibility Validation Team Members Abbreviations Pre-requisite for Validation Manufacturing Procedure Under Validation Critical Process Steps and Process Parameters for Validation with Justification Process steps – Sampling and Analysis Plan with Acceptance Criteria …
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