Industrial quality assurance and GMP
The perception of quality is for each person different.
Quality
- “fit for use”: drug is suitable for the intended purpose
- Effective
- Safe
- Drug meets the expectations of the patient
- Preventing mistakes
The cause of formulation of quality guidelines is the mistakes being made in pharmacy field.
Number of recalls doesn’t decrease because of
1. Doubt whether the quality systems work sufficiently
2. The awareness of mistakes being made due to the existing quality systems
Due to the better systems more recalls
Prevent label error: applied labels should be the same as the produced labels.
Fraud, deception (bedrog), corruption
- Mainly in China
Pollution of a solvent
When Europe imports an excipient, they should do the quality test.
Companies often don’t get a serious punishment
Say what you do Do what you say Prove it Improve it
- SOPs - Continuous - Process - PCT
- Quality verification monitoring - Continuous
systems - Risk assessment - PCT improvemen
- GMP - Quality risk - PAT t
management - Validation - QBD
Responsible authorities set up good practices
- GMP: Good manufacturing practices
Rules you have to follow if you want to make pharmaceutical products
Chemistry, pharmacy, production, analytics
Adequate ways to produce drugs
- GLP: Good Laboratory Practices
Analytical control laboratories, non-clinical safety studies
Set of rules how to control materials
- GCP: Good Clinical Practices
How to test products whether it is active/safe
- GDP: Good Distribution Practices + Good Documentation Practices
traceability: trace back wherever the product went)
, - GRP: Good Registration Practices
assure the reliability of data
In each company should be a quality assurance system (QA)
- Quality Assurance is a wide-ranging concept, which covers all matters, which
individually or collectively influence the quality of a product.
- It incorporates a.o. GMP and QC (quality control)
- Ensures products are safe, effective and of adequate quality
- Is relevant to all levels in the company (USA: directors go to jail)
- Includers also suppliers, distributers and wholesalers
- Describes who is legally responsible (qualified person: allowed to release the drug on
the market)
QA principle
“The holder of a Manufacturing Authorization must manufacture medicinal products so as to
ensure that they are fit for their intended use, comply with the requirements of the
Marketing Authorization and do not place patients at risk due to inadequate safety, quality
or efficacy..”
“To achieve the quality objective reliably there must be a comprehensively designed and
correctly implemented system of Quality Assurance incorporating Good Manufacturing
Practice, Quality Control and Quality Risk Management.”
What is the meaning of GMP?
- A set of rules
- Part of Quality Assurance which ensures that products are consistently produced
(reproducible) and controlled to the quality standards appropriate to their intended
use and as required by the Marketing Authorization or product specification.
GMP European law
Volume 1: Pharmaceutical legislation (human)
Volume 2: Note to applicants (human)
Volume 3: guidelines (human)
Volume 4: good manufacturing practices
Volume 5: pharmaceutical legislation (veterinary)
Volume 6: note to applicants (veterinary)
Volume 7: medicinal products (veterinary)
Volume 8: maximum residue limits guidelines (veterinary)
Volume 9: pharmacovigilance
Volume 10: clinical trials
Other GMP guidelines
FDA (food drug administration): no power of law
WHO (world health organization): 99% same as GMP.
Other quality assurance systems:
ISO and HACCP: for excipients in food, assure safety efficacy final product
The perception of quality is for each person different.
Quality
- “fit for use”: drug is suitable for the intended purpose
- Effective
- Safe
- Drug meets the expectations of the patient
- Preventing mistakes
The cause of formulation of quality guidelines is the mistakes being made in pharmacy field.
Number of recalls doesn’t decrease because of
1. Doubt whether the quality systems work sufficiently
2. The awareness of mistakes being made due to the existing quality systems
Due to the better systems more recalls
Prevent label error: applied labels should be the same as the produced labels.
Fraud, deception (bedrog), corruption
- Mainly in China
Pollution of a solvent
When Europe imports an excipient, they should do the quality test.
Companies often don’t get a serious punishment
Say what you do Do what you say Prove it Improve it
- SOPs - Continuous - Process - PCT
- Quality verification monitoring - Continuous
systems - Risk assessment - PCT improvemen
- GMP - Quality risk - PAT t
management - Validation - QBD
Responsible authorities set up good practices
- GMP: Good manufacturing practices
Rules you have to follow if you want to make pharmaceutical products
Chemistry, pharmacy, production, analytics
Adequate ways to produce drugs
- GLP: Good Laboratory Practices
Analytical control laboratories, non-clinical safety studies
Set of rules how to control materials
- GCP: Good Clinical Practices
How to test products whether it is active/safe
- GDP: Good Distribution Practices + Good Documentation Practices
traceability: trace back wherever the product went)
, - GRP: Good Registration Practices
assure the reliability of data
In each company should be a quality assurance system (QA)
- Quality Assurance is a wide-ranging concept, which covers all matters, which
individually or collectively influence the quality of a product.
- It incorporates a.o. GMP and QC (quality control)
- Ensures products are safe, effective and of adequate quality
- Is relevant to all levels in the company (USA: directors go to jail)
- Includers also suppliers, distributers and wholesalers
- Describes who is legally responsible (qualified person: allowed to release the drug on
the market)
QA principle
“The holder of a Manufacturing Authorization must manufacture medicinal products so as to
ensure that they are fit for their intended use, comply with the requirements of the
Marketing Authorization and do not place patients at risk due to inadequate safety, quality
or efficacy..”
“To achieve the quality objective reliably there must be a comprehensively designed and
correctly implemented system of Quality Assurance incorporating Good Manufacturing
Practice, Quality Control and Quality Risk Management.”
What is the meaning of GMP?
- A set of rules
- Part of Quality Assurance which ensures that products are consistently produced
(reproducible) and controlled to the quality standards appropriate to their intended
use and as required by the Marketing Authorization or product specification.
GMP European law
Volume 1: Pharmaceutical legislation (human)
Volume 2: Note to applicants (human)
Volume 3: guidelines (human)
Volume 4: good manufacturing practices
Volume 5: pharmaceutical legislation (veterinary)
Volume 6: note to applicants (veterinary)
Volume 7: medicinal products (veterinary)
Volume 8: maximum residue limits guidelines (veterinary)
Volume 9: pharmacovigilance
Volume 10: clinical trials
Other GMP guidelines
FDA (food drug administration): no power of law
WHO (world health organization): 99% same as GMP.
Other quality assurance systems:
ISO and HACCP: for excipients in food, assure safety efficacy final product
