Tag: Aberdeenshire

Procedure For Good Documentation Practices

Posted on By ABHA

STANDARD OPERATING PROCEDURE Title :  Procedure For Good Documentation Practices Department : Quality Assurance OBJECTIVE                                                       To lay down a procedure for good documentation practices. SCOPE This procedure is applicable for all Production, Quality Control, Quality Assurance, Warehouse, Engineering & utility and Personnel and Administration departments. RESPONSIBILITY Officer/Executive-QA. ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Design and Preparation…

Read More “Procedure For Good Documentation Practices” »

SOPs

Procedure for Surface Monitoring of Equipment by Swab

Posted on By ABHA

STANDARD OPERATING PROCEDURE Title : Procedure for Surface Monitoring of Equipment by Swab Department : Quality Control-Microbiology   OBJECTIVE To lay down a procedure for surface monitoring of equipment by swab. SCOPE This SOP is applicable for surface monitoring of equipment by swab in microbiology laboratory. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of…

Read More “Procedure for Surface Monitoring of Equipment by Swab” »

SOPs

Procedure for handling of cultures & contaminated material

Posted on By ABHA

 STANDARD OPERATING PROCEDURE Title :Procedure for handling of cultures & contaminated material Department:Quality Control-Microbiology OBJECTIVE To lay down a procedure for handling of cultures & contaminated material. SCOPE This SOP is applicable for handling of cultures & contaminated material in microbiology laboratory . RESPONSIBILITY Officer / Executive- QC M – responsible for Implementation of SOP….

Read More “Procedure for handling of cultures & contaminated material” »

SOPs

MFR of Pantoprazole Sodium 40 mg and Domperidone 10 mg Tablets in Pharma Industry

Posted on By ABHA

MFR of Pantoprazole Sodium 40 mg and Domperidone 10 mg Tablets in Pharma Industry  TABLE OF CONTENTS  S.NO. TITLE Page No 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENTS 4.0 MANUFACTURING INSTRUCTIONS 5.0 GENERAL PRECAUTIONS 6.0       MANUFACTURING PROCESS DETAILS 6.1 GRANULATION 6.2 COMPRESSION 1.0 PRODUCT DETAILS: Product Name Pantoprazole Sodium…

Read More “MFR of Pantoprazole Sodium 40 mg and Domperidone 10 mg Tablets in Pharma Industry” »

Tablets

Procedure for preparation of disinfectant & cleaning of Microbiology Laboratory

Posted on By ABHA

STANDARD OPERATING PROCEDURE Title   : Procedure for preparation of disinfectant & cleaning of microbiology laboratory OBJECTIVE To lay down a procedure for preparation of disinfectant & cleaning of microbiology laboratory. SCOPE This SOP is applicable for disinfectant & cleaning of microbiology laboratory. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of SOP. ACCOUNTABILITY Manager…

Read More “Procedure for preparation of disinfectant & cleaning of Microbiology Laboratory” »

SOPs

Code to Code Transfer of Materials and Additional Testing of Materials / Products in Pharma Industry

Posted on By ABHA

Code to Code Transfer of Materials and Additional Testing of Materials / Products in Pharma Industry Objective To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard…

Read More “Code to Code Transfer of Materials and Additional Testing of Materials / Products in Pharma Industry” »

SOPs

AMOXICIILIN AND POTASSIUM CLAVULANATE TABLETS BP

Posted on By ABHA

MASTER FORMULA RECORD AMOXICILLIN AND POTASSIUM CLAVULANATE TABLETS BP           Purpose: To provide instructions for the preparation of Master formula Record. For Amoxicillin Trihydrate and Potassium Clavulanate 625 mg Tablets BP.  Objective: To provide a documented procedure for the preparation of Master formula record is that standard manufacturing/packing record which gives complete details of materials used…

Read More “AMOXICIILIN AND POTASSIUM CLAVULANATE TABLETS BP” »

MASTER FORMULAS

Procedure for handling of Microbiology Area

Posted on By ABHA

STANDARD OPERATING PROCEDURE Title : Procedure for handling of Microbiology Area Department : Quality Control-Microbiology     OBJECTIVE   To lay down a procedure for handling of microbiology area. SCOPE This SOP is applicable for handling of microbiology area. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of SOP. ACCOUNTABILITY Manager – Quality Control Manager –…

Read More “Procedure for handling of Microbiology Area” »

SOPs

Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution in Pharma Industry

Posted on By ABHA

Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution in Pharma Industry Objective To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant solution in Pharma Industry.  Scope This SOP is applicable for issuance, preparation, storage, usage and disposal of disinfectant solution in manufacturing area in Pharma Industry.  Responsibility GMP coordinator…

Read More “Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution in Pharma Industry” »

SOPs

Corrective and Preventive Action (CAPA) In Pharma Industry

Posted on By ABHA

Corrective and Preventive Action (CAPA) In Pharma Industry 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 In Pharma Industry. Scope This Standard Operating Procedure shall apply to all…

Read More “Corrective and Preventive Action (CAPA) In Pharma Industry” »

SOPs