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 name with location. Responsibility Trained…
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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 shall be responsible for compliance…
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 equipment as per this SOP….
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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 equipment as per this SOP….
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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 (For Instruments which shall be…
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 for usage of purified water…
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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 shall be responsible for compliance…
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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 Sintyl S.A. 9/29/16 Delarange Cosmetics…
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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, Inc 10/24/14 RX South DBA…
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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
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 Jobs and post Please click…
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 American Family Pharmacy, LLC 7/30/15…
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SOP On Document and Data Control Objective:To lay down a procedure for control of documents and documented data. Scope:This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible to follow this SOP for maintaining control…
Sop on Corrective and Preventive Action Objective : To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and/or recurrence. Scope : This Standard Operating Procedure shall apply to all corrective and preventive action taken in the…
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HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT To define a procedure for handling of market complaints. PRODUCT COMPLAINT SOP SCOPE This SOP shall be applicable to all the market complaints of drug products received directly or from any other source. DEFINITIONS Complaint: A market / consumer complaint is notification that a product in commercial distribution (which…
CHANGE CONTROL PROCEDURE
Sop on Assigning Manufacturing and Expiry date To lay down a procedure for assigning manufacturing and expiry dates to the finished products being manufactured. & This SOP is applicable for assigning manufacturing and expiry dates to the finished products being manufactured at (Pharmaceutical Company Name). Assigning Manufacturing and Expiry date – Responsibility & Accountability Production Personnel…
SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
REPROCESSING AND REWORKING SEMI-FINISHED AND FINISHED PRODUCTS PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
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…
