Tag Archives: Aberdeenshire

Operating Procedure for Tablet Hardness Tester (Erweka)

 Objective:To lay down the Operating procedure for Tablet Hardness Tester. Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Erweka. Responsibility Trained worker / Operator shall be responsible for operating of the equipment as per this SOP. Production Supervisor / Officer shall be …

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Calibration Procedure for Tablet Hardness Tester (Inweka)

Objective :To lay down procedure for Calibration of Tablet Hardness Tester (Inweka). Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location. Make: Inweka. Responsibility Operator shall be responsible for calibration of the equipment as per this SOP. Production Supervisor / Officer shall be responsible …

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SOP on Procedure for Leak Test

Objective: To lay down a procedure for Leak Test. 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 mentioned in this SOP. Head, Production shall be responsible for compliance of procedure as …

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SOP on Control of Sieves and Screens

SOP on Control of Sieves and Screens Objective: To lay down a procedure for Control of Sieves and Screens of different Equipments. Scope: This Standard Operating Procedure is applicable for the formulation plant of pharmaceutical company name with location. Responsibility Production Supervisor / Officer shall be responsible for implementation of …

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SOP on Control and Cleaning of S.S. items used in Production

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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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, …

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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 …

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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 …

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SOP On Document and Data Control

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 …

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Sop on Corrective and Preventive Action (CAPA)

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 …

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HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT

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 …

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HANDLING OF CHANGE CONTROL

HANDLING OF CHANGE CONTROL Change Control: Review, evaluation, approval and monitoring of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities. The change can be permanent or temporary. Permanent Change: Any planned introduction, addition, deletion or modification of Manufacturing Facility, Equipment, Utilities, Manufacturing Process, Material/Product, Specifications, and …

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