Microbiology

SOP for Microbiological Analysis of Water

1. Objective To lay down a procedure for microbiological analysis of water. 2. Scope This procedure is applicable for analysis of potable, purified and distilled water. 3. Responsibility Microbiology department 4. Procedure 4.1 Limits: Total viable count: Grade of Water Alert Limit   Action Limit   Target...

SOP for Microbiological Analysis of Compressed Air & Nitrogen

1. Objective To lay down a procedure for microbiological analysis of compressed air and Nitrogen. 2. Scope This procedure is applicable for microbiological analysis of compressed air and Nitrogen used at factory for manufacturing and testing. 3. Responsibility: Quality...

SOP for Failure Investigation in Pharmaceutical Industry

Objective: To lay down a procedure for failure investigation. Scope: This procedure is applicable for investigation of process or system failure having     impact on product quality, efficacy and patient safety. Responsibility: All concerned Department,...

Important SOPs for Microbiology Department in Pharmaceutical Industry

SOP for aerobic microbial count SOP for operation and maintenance of microscope SOP for operation and maintenance of BOD incubator SOP for sterility testing SOP for calibration, operation and maintenance of air sampler ...

SOP for Quality Management System (Documentation) in Pharmaceutical Industry

 Objective: To lay down a procedure for origination and review of the Site Master File, Quality     Manual, Quality Policy, SOPs, forms and logs. Scope: This procedure is applicable for following documents: - Quality Manual/Policy -  Site...

SOP for Incident Handling in Pharmaceutical Industry: PharmaState

1. Objective: To lay down a procedure for handling of incidents. Scope: This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents may occur even though standard procedures are not violated. ...

Procedure for Cleaning and Monitoring of Clean Room Pass Boxes

  Cleaning of Clean- Room Pass Boxes: (A) Subject:  Procedure for Cleaning of Class- Room Pass Boxes. (B) Purpose: This procedure is applicable for Cleaning of Clean- Room Pass Boxes used in the formulation plant of pharmaceutical...

Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA

Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances                          CATEGORY                             TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Pharmaceutical Quality/Manufacturing Standards (CGMP) Current...

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