Quality In Pharmaceutical Industry (Week 1) Flashcards
What is pharmaceutical QA?
The total sum of the organised arrangements made with the object of ensuring that medicinal products or investigational medicinal products are of the quality required for their intended use
What is manufacturer’s license?
Required by manufacturers before they can start to manufacture and sell pharmaceuticals
What is marketing authorisation?
Required for each product to be marketed in a particular formulation
What is the medicines and healthcare products regulatory agency (MHRA)
Agency of the department of health
Licenses pharmaceutical manufacturers and products
Authorises clinical trials
Provides info to public about side effects, patient information leaflets
How to get marketing authorisation?
Product must be adequate quality for intended use
Sufficiently safe and effective
Full toxicological, pharmacological and clinical data for new products
Renewed every 5 years
What is a qualified person (QP)
No medicine can be released for sale before signed off by QP
They certify each batch has been manufactured in accordance with marketing authority
QP must have professional qualifications
What are specials medicine?
Tailor made for specific individuals
Specials license required by manufactures
What is GMP?
The part of QA which insures that medicinal products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use
Pharmaceutical manufacturers massage your products are manufactured according to principles of GMP
Requirements of GMP?
All manufacturing processes are clear defined, systematically reviewed and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specification
Critical steps of manufacturing processes and significant changes to the process of validated - e.g. change in temperature, order materials are added
All necessary facilities for GMP are provided:
Appropriately qualified and trained personnel
Adequate space
Suitable equipment, storage and transport
Correct materials
Containers and labels
Instructions and procedures are written in an instructional form in a clear and ambiguous language specifically applicable to the facilities provided
Operators are trying to carry out procedures correctly
Records of manufacture including distribution which enable complete history of a batch to be retraced, are retained in a comprehensible and accessible form
The distribution of products minimises any risk to their quality
System is available to recall any batch of product
Complaints about products are examined, causes are investigated, appropriate measures taken to prevent recurrence
Quality control requirements in GMP?
Adequate facilities, trained personnel and approved procedures for sampling, inspecting and testing of starting materials, packaging materials, bulk products and finished products, and where appropriate environmental conditions
Samples are taken by personnel and methods approved by QC
Test methods are validated -
Is it correct test? Are instruments used correctly? Correct data given?
Records are made showing that all required sampling, is inspecting and testing procedures have been carried out
Finished products contain active ingredients complying with the qualitative and quantitive composition of the marketing authorisation, are of purity required, enclosed in proper containers, correctly labelled
Records are made of the results of inspections and that testing of materials is formally assessed against specification
No batch is released for sale or supply prior to certification by a qualified personnel that is in accordance with the requirements of the marketing authorisation
Reference samples of starting materials and products retained for future examination if required, and product retained in final pack, unless too large
Cleaning protocols?
GMP requires strict cleaning protocols of equipment between batches
Must be able to prove equipment is cleaned between batches
Need to consider detergents used are also cleaned off, swabbing
Case study
Product A batch completed and vessel cleaned, however some left over, falls into reaction of product B, patient may experience adverse reaction
GxP definitions?
GMP - Good manufacturing practice
GDP - Good distribution practice
GCP - Good clinical practice
GPvP - Good pharmacovigilance
What is Good Distribution Practice?
That part of QA which ensures products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation
Regulated by MHRA
Pharmaceuticals must be distributed/stored correctly
What is Good Clinical Practice?
A set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people
Regulated by MHRA
What is Good Pharmacovigilance Practice?
On going monitoring on pharmaceuticals
Minimum standard for monitoring safety of medicines on sale to public in the UK - related to any adverse effects
