Lecture 3: Good manufacturing practice Flashcards
What defines medicine?
A drug with proved safety, efficacy and quality
When is a medicinal product fit for its purposes?
It is made to the correct formula, free from contamination has not deterioated it is in the right and properly sealed container It is correctly labelled
What does the manufacture of medicinal products need to comply with?
the drug regulatory and GMP requirements
to their specifications as outlined by the pharmacopoeias
When is good manufacturing practice used?
Used in the manufacture of medicines as a mean to enforce stringent and consistent product quality
What are the other good practices?
Good laboratory practice
Good distribution practice
Good clinical practice
What is GMP?
set of principles and procedures which help to ensure products manufactured will have the same required quality. These are followed in the manufacturing of therapeutic products
What is the basic principle of GMP?
quality must be built into each batch of product during all stages of the manufacturing process
What are the reasons for GMP?
A small number of defective products, or wrongly labelled items present in a batch can still be a very serious danger to patients.
Patients are not very good at detecting if there is anything wrong in the product so GMP must be employed
why is GMP sometimes referred to as cGMP?
cGMP = current GMP which indicates that manufacturers must employ technologies and systems which are up to date in order to comply with the regulation
Whenever the law is added or ammended it becomes the current GMP
What does GMP cover?
Plant Products People Processes Paperwork
What sort of GMP is incorporated in NZ?
the NZ code of GMP for manufacture and distribution of therapeutic goods.
Medsafe requires GMP certification for products regarded as medicines in NZ (even if NZ was not their country of manufacture.)
Which GMP certifications are recognised by Medsafe?
the member authorities of the PIC/S e.g. Australia therapeutic goods agency
US FDA
UK Medicines & Healthcare Products Regulatory Agency etc.
What is PIC/S?
Pharmaceutical inspection convention scheme.
This is a cooperative arrangement between health authorities in the field of GMP
What is the NZ code of GMP based on?
the PIC/S guide to GMP
What are the goals of PIC/S?
- mutual recognition of inspections
- harmonisation of GMP requirements
- Uniform inspection systems
- training of GMP inspectors
- Exchange of information and experience in the field of GMP and related areas.
What are the benefits of PIC/S membership?
Ensures all members comply with PIC/S standards
Allows cost savings due to PIC/S allowing shared GMP inspection reports
Facilitates exporting as PIC/S and non-PIC/S members affect GMP certificates from PIC/S participiating authorities
Enhanced market access and therefore enhanced sales
What are the NZ GMP guidelines?
quality management personnel premises and equipment documentation production quality control contract manufacture and analysis complaints and product recall self inspection
What are the main components of quality management?
quality assurance
GMP
quality control
What is quality assurance?
wide ranging concept covering all matters which influence the quality of a product.
The sum total of organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.
What is GMP in terms of quality management?
GMP is the part of the quality assurance which ensures medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use.
What are the two main things GMP is concerned with?
production
quality control
What is quality control?
the part of the GMP that involves sampling, specifications, testing, documenting and releasing procedures.
This ensures products are not released for use or sale until their quality has been judged to be satisfactory
What is good laboratory practice?
set of principles and procedures which when followed by lab studies, help ensure generate data can be used to assess hazards and risks