Category: Microbiology

MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE

Posted on By Pharmaceutical Guidanace

MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE PURPOSE: To describe microbiological test controls to be applied for outsourced and in house drug substances, drug products and excipients. SCOPE: This SOP is applicable to drug substances, drug product, sterile drug product and excipients tested for microbiological quality. RESPONSIBILITY: Microbiologist shall be responsible for carrying…

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Microbiology

HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB

Posted on By Pharmaceutical Guidanace

HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB PURPOSE: To outline the procedure for Handling Biohazardous Material in the Microbiology Lab. SCOPE:  This procedure is applicable for Handling Biohazardous Material in the Microbiology Lab. REFERENCE(S) & ATTACHMENTS REFERENCES In-House ISO 45001:2018 CROSS-REFERENCE DOCUMENTS Preparation, Review, Approval, Issuance & Retrieval of Standard Operating Procedures (SOPs) Change Control…

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Microbiology

SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT

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SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT To lay down a procedure for establishment of Alert Limit and Action Limit. ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT OF SCOPE This SOP is applicable to critical stages of system, analytical test / Microbial test, on-line result regarding water system, process, product and environmental condition…

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Microbiology

GOOD MICROBIOLOGY LABORATORY PRACTICES

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GOOD MICROBIOLOGY LABORATORY PRACTICES To provide general guidance on Good laboratory practices in microbiology laboratory consisting of activities that depend on several principles, aseptic techniques, control of media, control of test strains, and control of equipment’s, personnel hygiene, health and garments. SCOPE GOOD MICROBIOLOGY LABORATORY PRACTICES: This SOP is applicable for Microbiology lab. RESPONSIBILITY: Concerned…

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Microbiology

BET and sterility validation of microbiology 

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BET and sterility validation of microbiology  BET and sterility validation of microbiology consists of the following:- Protocol No. for BET and sterility validation should be written in format PR/MV/AA/ BB/CC/DD and report No. should be written in format RP/MV/AA/ CC/DD . PR refers to protocol, RP refers to Report, MV refers to microbiology validation. AA…

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Microbiology

Isolators In Pharma Industry

Posted on By Abha Maurya

Isolators In Pharma Industry Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated cleanrooms. Isolators typically feature built-in…

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Production, Microbiology

Microbiological Efficacy of the Cycle

Posted on By Abha Maurya

Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production cycle need to estabilished. A sterility assurance of 10 or -6 better should be demonstrated for any terminal sterilization process. The level of sterility assurance should be demonstrated for all parts of the drug product (including the container and closure,…

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Microbiology

Microbiological Monitoring of the Environment

Posted on By Abha Maurya

Microbiological Monitoring of the Environment The microbiological monitoring program shall be performed during routine production and media fills and procedure for microbiological monitoring program are clearly defined in SOP. Microbiological monitoring – frequency of monitoring, type of monitoring, sites monitored, alert and action level specifications, and clearly defined procedure for actions taken when specifications are…

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Microbiology

Operation, cleaning and maintenance of Static Pass Box.

Posted on By Anshu Rani

 Functioning, cleaning and maintenance of Static Pass Box. Objective: To lay down the method for the ordinary operation, cleansing and preservation of the Static Pass Box (SPB). Scope: This SOP is relevant to the Static Pass Box present inside the microbiology lab. Responsibility: Chemist or above of QC laboratory. Head – Microbiology Section. Accountability: Head…

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Microbiology

STERILITY ASSURANCE

Posted on By Abha Maurya

STERILITY ASSURANCE 〈1211〉 INTRODUCTION Definition of sterility – An item is deemed sterile only when it contains no viable microorganisms. However, this textual definition cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing. Sterility cannot be demonstrated without the destructive testing of every sterile unit. In a real sense, microbiological…

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Microbiology

Functioning, cleaning and maintenance of Dynamic Pass Box

Posted on By Anshu Rani

Functioning, cleansing and maintenance of Dynamic Pass Box Objective: To lay down the method for the habitual operation, cleansing and renovation of the Dynamic Pass Box (DPB). Scope: This SOP is relevant to the Dynamic Pass Box present inside the microbiology lab Responsibility: Chemist or above of QC laboratory. Head – Microbiology Section. Accountability: Head…

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Microbiology

Functioning, cleaning and maintenance of Sterile Garment Cabinet

Posted on By Anshu Rani

Functioning, cleansing, and maintenance of Sterile Garment Cabinet Objective: To lay down the system for the ordinary operation, cleansing and protection of the Sterile Garment Cabinet (SGC). Scope: This SOP is relevant operation cleansing and protection of the Sterile Garment Cabinet present in the microbiology lab. Responsibility: Chemist or above of QC laboratory:. Head –…

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Microbiology

SOP on Operation, Calibration, Cleaning and Maintenance of LAF

Posted on By Anshu Rani

SOP on Functioning, Calibration, Cleaning, and Maintenance of LAF Objective: Technique for functioning, Calibration, Cleaning, and Maintenance of LAF. Scope: This SOP is relevant for the Operation, Calibration, Cleaning, and Maintenance of LAF in the Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control. Procedure:  …

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Microbiology

Effectiveness of Antimicrobial Preservatives in Pharma industry

Posted on By Pharmaceutical Guidanace

Effectiveness of Antimicrobial Preservatives in Pharma industry The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product. The primary purpose of adding antimicrobial preservatives in Pharma industry to dosage forms is to prevent…

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Microbiology

All Post URL of Drugs formulations

Posted on By Pharmaceutical Guidanace

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride Tablet (drugsformulations.com) Norethisterone Tablet (drugsformulations.com) Metformin…

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Audit and Guideline, Engineering, Microbiology, Production, Quality Assurance, Quality Control, USFDA WARNING LETTER, Validation & Qualification, Warehouse

UV efficacy Challenge test

Posted on By Pharmaceutical Guidanace

UV efficacy Challenge test Evaluation of ultraviolet irradiation efficacy in an automated system for the aseptic compounding using challenge test Objective Ultraviolet (UV) irradiation efficacy in the intravenous compounding robot APOTECA chemo was evaluated to define the best operative conditions in terms of sterility and time optimization. Design The challenge test was used against Pseudomonas aeruginosa, Escherichia…

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Microbiology

SOP on Testing Efficacy of Disinfectants

Posted on By Pharmaceutical Guidanace

SOP on Testing Efficacy of Disinfectants. Objective: To lay down a procedure for testing efficacy of Disinfectants. Scope : This SOP is applicable for testing of efficacy of disinfectant solutions used in  microbiology laboratory and production area. Responsibility Microbiologist Head-Microbiology Accountability Head-Quality Control Head-Quality Assurance Procedure Prepare Culture suspension of Escherichia coli ATCC 8739, Candida…

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Microbiology

SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

Posted on By Pharmaceutical Guidanace

Personnel Qualification for Aseptic Processing and Sterility Testing Area Objective: To lay down the procedure for Personnel Qualification to enter and work in the Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area Procedure: For the Aseptic Processing Area The…

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Microbiology

SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

Posted on By Pharmaceutical Guidanace

Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control Head…

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Microbiology