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 …
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 …
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 …
SOP on Maintenance and Preparation of Anaerobic Culture Suspension. Read More »
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 …
Why Self Inspection is Important in Pharmaceuticals industry …? Self inspection is mandatory by Regulatory Authorities like MHRA, EU, and USFDA. It is one of QMS tools to see that Quality of Product is not compromised by any component of manufacturing site. Self inspection should be conducted to check effectiveness & compliance with Good Manufacturing …
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 …
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 …
