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

SOP on Change control The purpose of this SOP is to lay down a procedure to “Change Control” to ensure that the proposed changes shall not affect the strength, identity, safety, purity and quality of the product. PROCEDURE: TYPES OF CHANGE CONTROL: DOCUMENT CHANGE CONTROL (DC) : Initiation of a document or modification of approved …

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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 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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