SOP on Handling of Incidents and Deviations

SOP on Handling of Incidents and Deviations PROCEDURE: Definition: Departure from an approved instruction or established standard. Deviation shall be lodged when deviation from the written procedure is observed / taken from following documents (but not limited to): SOP BMR BPR STP SPEC. No deviation is permitted from Pharmacopoeia and other Regulatory specifications. However additional […]

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Drug Regulatory Affairs – CTD

Drug Regulatory Affairs – CTD. Drug Regulatory Affairs in Pharma Industry plays important role as all departments of Pharma product Manufacturing Like Quality Assurance, Quality Control, Production, Microbiology also same as Formulation & Development Department & Analytical Development Department. Drug Regulatory Affairs comes in last stage of Product Preparation & distribution like after complete & successful

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SOP on Maintenance and Preparation of Anaerobic Culture Suspension.

SOP on Maintenance and Preparation of Anaerobic Culture Suspension ( Clostridium Sporogenes ). This procedure is for Maintenance & preparation of culture suspension for anaerobic microorganisms in Microbiology Department.  it includes maintenance of culture & preparation of culture suspension as per Culture Dilution Method. PROCEDURE: Maintenance: Prepare Nutrient Agar as per Media preparation SOP Pour 5 mL

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SOP on Change Control

Mastering Change Control in the Pharmaceutical Industry: A Guide to Quality and Compliance Navigate the intricacies of change control with this comprehensive guide! Ensuring the safety, efficacy, and quality of pharmaceutical products hinges on meticulous control over changes. This SOP dives into the essential steps and considerations for implementing an effective change control system in

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SOP For Training of employees

Training of employees PROCEDURE:                   Every employee of the organisation shall first undergo an Induction Training and then to be trained on his / her area of operation prior to start the work. Induction Training shall also include a visit and understanding of works done in Departments other than their own. An Induction Training Record

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Microbiology Microbiology is the crucial section of Sterile Pharmaceutical products, it is very Important in Non- Sterile Products. Microbiology section is divided in following sections;  Antimicrobial Effectiveness Testing.(USP <51>)(Ph. Eur. general texts 5.1.3)  Microbial Examination of Non-Sterile Products.( USP <61>,<62>)(Ph. Eur. method 2.6.13./2.6.12) Sterility Testing.(USP <71>),(Ph. Eur. method 2.6.1) Bacterial Endotoxin Testing.( USP <85>) Particulate

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