QUALITY MANUAL Flashcards
Explain the typical structure and content of a Quality Manual in a pharmaceutical company.
im can individual familiar people show quickly on front rear.
content – sections with QM and page numbers
introduction – brief description of QM
facilitiy background – location and product being manufactured
purpose – why and how QM will be used
scope – list of regulatory requirement to be followed and those that wont be followed and a reason as to why they wont be followed.
quality policies and objectives – statements of the facilities approach to quality and expecatation to complywith regulatory reuqirements and facilitate continual improvement
organisation and structure of documentation – how documentation is structured and orgnaised in facilties
facilities product - brief descrption of the product
references – list of regulatory requirement cited
identification of process within pqs with flow chart and maps
management responsibitlies with PQS
