SOP on Usage of purified water for batch manufacturing and cleaning purpose Objective: To lay down a procedure for usage of purified water for batch manufacturing and cleaning purpose. Scope: This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location. Responsibility Operator shall be responsible …
Read More »SOP on Disposal of Non-Recoverable In-process Materials
SOP on Disposal of Non-Recoverable In-process Materials Objective: To lay down a procedure for disposal of non-recoverable in-process materials. Scope: The standard operating procedure is applicable for formulation plant of Pharmaceutical Company name with location. Responsibility Production-Supervisor / Officer shall be responsible for implementation of this SOP. Production-Head / designee …
Read More »USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma
USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma Noven Pharmaceuticals, Inc. 8/5/16 Huzhou Aupower Sanitary Commodity 8/10/16 Frontida BioPharm Inc 8/15/16 College Pharmacy Incorporated 8/15/16 Ajes Pharmaceuticals LLC 9/9/16 Mappel Industria de Embalagens S.A. 9/12/16 Cheng Fong Chemical Co., Ltd. 9/15/16 Yangzhou Hengyuan Daily Chemical Plastic Co Ltd 9/26/16 Laboratoire …
Read More »USFDA WARNING LETTER 2014 (Finished Pharmaceuticals) in Pharma
USFDA WARNING LETTER 2014 (Finished Pharmaceuticals) in Pharma Usv Limited 2/6/14 SmithKline Beecham (Cork) Ltd. 3/18/14 Sun Pharmaceutical Industries Limited – Karkhadi 5/7/14 Apotex Pharmachem India Pvt Ltd. 6/16/14 M.D. Science Lab 7/15/14 Zions Rx Formulations Services LLC dba Rx Formuations Serv. 8/15/14 Wells Pharmacy Network LLC 11/10/14 Pharmagen Laboratories, …
Read More »USFDA WARNING LETTER 2014 (API) in Pharma
USFDA WARNING LETTER 2014 (API) in Pharma Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14 Sharp Global Limited 10/15/14 CBSCHEM LIMITED 1/31/14 Pharma More Jobs and post Please click here
Read More »USFDA WARNING LETTER 2015 (API) in Pharma
USFDA WARNING LETTER 2015 (API) in Pharma Cadila Pharmaceuticals Limited 2/25/15 Sandoz Private Limited 10/22/15 Dr. Reddy’s Laboratories Limited 11/5/15 Zhejiang Hisun Pharmaceutical Co., Ltd. 12/31/15 Cadila Healthcare Limited 12/23/15 Unimark Remedies Ltd. 9/28/15 Sipra Labs Limited 7/23/15 Yunnan Hande Bio-Tech. Co. Ltd. 4/6/15 MyNicNaxs, Inc. 2/20/15 Pharma More …
Read More »USFDA WARNING LETTER 2015 (Finished Pharmaceuticals) in Pharma
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 …
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