SOP on Control and Cleaning of S.S. items used in Production Objective: To lay down a procedure for Control and Cleaning of S.S. items used in Production. Scope: This standard operating procedure is applicable for Control and Cleaning of S.S. items used in Production, at formulation plant of pharmaceutical company …
Read More »SOP on Procedure of Packaging Lines Control
SOP on Procedure of Packaging Lines Control Objective:To lay down a procedure for packaging lines control. Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location. Responsibility Production Supervisor / Officer shall be responsible for implementation of the procedure as per this SOP. Head, Production …
Read More »SOP on Operating Procedure for Disintegration Test Apparatus
SOP on Operating Procedure for Disintegration Test Apparatus Objective: To lay down the Operating Procedure for Disintegration Time Apparatus. Scope: This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Electro lab. Responsibility Trained worker / Operator shall be responsible for operating of the …
Read More »SOP on Calibration Procedure for Disintegration Test Apparatus
SOP on Calibration Procedure for Disintegration Test Apparatus Objective :To lay down procedure for Calibration of Disintegration Test Apparatus. Scope :This standard operating procedure is applicable for formulation plant of pharmaceutical company name with Location. Make: Electro lab. Responsibility Trained worker / Operator shall be responsible for operating of the …
Read More »SOP on Calibration of Production Instruments
SOP on Calibration of Production Instruments Objective :To lay down a general procedure for calibration of production instruments. Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location. Responsibility Production Supervisor / Officer shall be responsible for calibration of production instruments as per this SOP …
Read More »SOP on Usage of purified water for batch manufacturing and cleaning purpose
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 …
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