Category: SOPs

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…

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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….

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SOPs

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…

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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…

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SOPs

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 –…

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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…

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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…

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SOPs

Organogram in Pharma Industry

Posted on By ABHA

Organogram in Pharma Industry in Pharma Industry Objective To describe the procedure for preparation of Organogram in Pharma Industry. Scope This procedure is applicable for preparation of organograms of all the departments in Pharma Industry. Responsibility P&A Department is responsible for preparation of organogram. Head – User department is responsible for review of respective Organograms….

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SOPs

Cleaning Policy of Area and Equipment in Pharma Industry

Posted on By ABHA

Cleaning Policy of Area and Equipment in Pharma Industry Objective           To lay down the procedure for Cleaning Policy of Area & Equipment in Pharma Industry. Scope This Standard Operating Procedure is applicable to all the departments at the formulation plant in Pharma Industry. Responsibility Production Operator/ Technician shall be responsible for cleaning. Production &…

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SOPs

Procedure for autoclave validation

Posted on By ABHA

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

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SOPs