audit Flashcards
What are first party( internal audit) second party and third- party audits? how would it be undertaken?
Internal: (First party, self) – An audit conducted by company employees or contractors/ consultants.
External: Supplier audit (second party) – This is where customer employees audit your company
- employees audit a company that supplies your company with a product or service.
Independent Organisation: (third party) – A customer wants an audit of your company but wants your company to pay for it/ certification audit.
Discuss the purpose of and importance of self-inspection.
- To meet a regulatory requirement,
- To look for areas for improvements,
- To ensure procedures are being followed correctly
- order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.
- Monitor conformance to the companies quality system and regulatory requirements.
- verify activities conforms with the principles of Quality Assurance
How are audit non-conformances often categorised? How are GMP audit non -conformances normally classified in Ireland? How are GMP Regulatory audit non -conformances normally classified?
Critical deficiency
- produced/lead to significant risk of producing either a product which is harmful to human/veterinary patient.
Major deficiency
- produce/may produce a product which does not comply with its marketing authorisation.
- Major deviations from GMP
- Combination of several ‘other’ deficiencies, on their own not majors deficiency but all together represent major deficiency.
- Failure to carry out satisfactory procedure for release of batches.
- Failure of QP to fulfil their duties.
Other deficiency
- Can’t be classified as either majors or critical but indicates departure from GMP.
- Judged as minor and insufficient information to judge as major or critical.
What are adequacy and compliance audits and process audits what is the purpose of each?
System/ adequacy audits? → It is a desk audit which determines the extent to which the documented systems in place adequately meet the requirements of the applicable standard.
* Work through the relevant standard/regulation clause by clause and find the part of the documented system which applies.
compliance audits? → It seeks to establish the extent to which the documented system is implemented and observed by the workforce.
* review organisations adherence to regulatory requirements.
What is a process audit? → It is concerned with the validity and overall reliability of any particular process
What are adequacy and compliance audits and process audits what is the purpose of each?
System/ adequacy audits? → It is a desk audit which determines the extent to which the documented systems in place adequately meet the requirements of the applicable standard.
* Work through the relevant standard/regulation clause by clause and find the part of the documented system which applies.
compliance audits? → It seeks to establish the extent to which the documented system is implemented and observed by the workforce.
* review organisations adherence to regulatory requirements.
What is a process audit? → It is concerned with the validity and overall reliability of any particular process
