Bacterial Endotoxin Test GTP
Bacterial Endotoxin Test GTP
Category: Microbiology
MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE
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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HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB
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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SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT
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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GOOD MICROBIOLOGY LABORATORY PRACTICES
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…
BET and sterility validation of microbiology
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…
Isolators In Pharma Industry
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…
Microbiological Efficacy of the Cycle
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,…
Microbiological Monitoring of the Environment
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…
Sterility Test USP (GTP)
Sterility Test USP (GTP)
STERILITY ASSURANCE
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…
Particulate Matter ( GTP )
Particulate Matter ( GTP )
GTP Microbial Limit Test (MLT )
GTP Microbial Limit Test (MLT )
SOP on Operation, Calibration, Cleaning and Maintenance of LAF
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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Effectiveness of Antimicrobial Preservatives in Pharma industry
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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All Post URL of Drugs formulations
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…
UV LAMP EFFICACY TEST
UV LAMP EFFICACY TEST WHAT IS UV LIGHT? The light with a wavelength of 10-400 nano meters (nm) in sunlight is called ultraviolet light, and it can be divided into UVA, UVB, and UVC (200 nm to 275 nm) according to different wavelength bands. Among them C-band ultraviolet rays destroy the DNA of bacteria and…
UV efficacy Challenge test
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…
SOP on Testing Efficacy of Disinfectants
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…
SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area
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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