sia Flashcards
Medicinal Products/APIs with false representation
These may include falsified:
- Name of Manufacturer
- Name of Market
- Authorization Holder
- Batch Number
- Packaging/Labelling
- Identity/Composition
- Manufacturing Records/Certificates of Analysis
Consumers put their Trust in Manufacturers & Suppliers and also in the Regulators/Inspectors.
to
- To weed out adulterated, counterfeits & falsified products
- To ensure safe, efficacious & quality products
- To oversee drug/API manufacturing & supply chain
(1) Role of HSA as a (Health Product) Regulatory Agency
- To wisely regulate health products
- To safeguard public health
GMP aims to build quality into a product at all stages of its manufacture from:
- Design of medicinal product (formulation of dosage form)
- Procurement/QC of starting materials
- Production of intermediate/bulk products & IPQC
- Filling/packaging/labeling of finished product
- Final QC testing of finished product before release
Limitations of Conventional Product Testing
- You test only a “representative” sample size
- You can test only if you know the analyte and you have a test method
- You can test only if test method is specific, accurate and reliable, i.e if it is validated.
A Medicinal Product is fit for its intended purpose, if:
- It is the right product (made according to a predetermined formula and method)
- It is of the right strength, in the right container and correctly labelled.
- Free from contamination
- Not deteriorated or broken down
- Properly sealed in its container and protected against damage and contamination
- Consistently of the quality specified by the manufacturer and approved by the regulator.
quality of medicine/health product has to include
- Identity (of starting material)
- Potency (of starting material, especially active pharmaceutical ingredients)
- Purity (freedom from contaminants and impuriries)
- Pharmaceutical Quality Attributes (of finished dosage form)
o Hardness, Friability, particle size, dissolution profile, pH, clarity, Color index, Microbial limits, sedimentation rate, viscosity, sterility, Endo-toxin levels - Stability, homogeneity
PIC/S GMP how many chapters and annexes
9 chapters
20 annexes ——> annex 18 is empty
Pharmaceutical quality system chapter
1
personnel chapter
2
premises and equipment chapter
3
documentation chapter
4
production (including packaging) chapter
5
quality control chapter
6
outsource activity chapter
7
complaints and product recall chapter
8
self inspection chapter
9
sterile product annex
1
biological product annex
2
radiopharmaceuticals annexx
3
vet product nonimmunologiical annes
4
vet product immunologiical annes
5
medicinal gases annex
6
herbal annex
7
sampling annex
8
liquid creams and ointment annesx
9
inhalation annex
10
computerised system annex
11
ionizing radiaiton annex
12
investigational medicinal products annex
13
blood product annes
14
process validation annex
15
qualified person applicable to EU only annex
16
parametric release annex
17
empty annex
18
retention sample annex
19
quality risk management annex
20
intrinsic contaminants
present inherently in APIs, excipients (including water) and packaging materials used in formulating product
not removed competely from starting and packaging materials during their manufacturing processes
referred to as impurities - often specific in nature.
- Process-related impurities (during synthesis of API)
• Un-reacted API starting material/intermediates
• Residual reagents and catalysts
• Residual solvents
• Residual heavy/other metals
• By-products. - Drug-related impurities
• Degradation products (after API is formed)
3. polymorphs • Ampicillin • carbamazepines • cimetidine • mefenamic acid • omeraprazole • ranitidine HCL
4. stereo-isomers • Dopamine • propranolol • Dex-chlorpheniramine • guaifenesin • lisinopril dihydrate
- impurities from primary container and labels
extrinsic contaminants
originate externally from
production personnel
processing equipment
packaging equipment
manufacturing premises (env)
often non-specific in nature.
