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 …
