Pharmaceuticals Sector
Pharmaceuticals Testing, Certification and Conformity
Overview
Pharmaceuticals sector: an overview of conformity processes
GMP is a legal requirement in pharmaceutical manufacturing and is audited by the competent health authority; this is a licensing requirement, not a certification. On the analytical side, pharmacopoeia methods (EP, USP) and ICH guidelines are decisive; ISO 15378 is used for primary-packaging suppliers.
How we work
Six steps from scope to certificate
Scope
We determine your product, target market and sector; the required legislation list is produced.
Quote
Testing and audit items are priced separately; the quote is delivered within 24 hours.
Sample / Planning
Sample requirements are shared, or an on-site audit is scheduled.
Testing & Audit
Testing or audit is carried out according to the method of the relevant standard.
Report & Document
A report is issued; if within certification scope, the process proceeds to the decision stage.
Maintaining the validation
Surveillance audits and legislative changes are tracked.
Product groups
Pharmaceuticals sector: what do we test?
- 01Human and veterinary medicines
- 02Active pharmaceutical ingredients (API) and excipients
- 03Primary packaging materials
- 04Sterile products and parenterals
- 05Food supplements
Services
The work we carry out in this sector
From testing laboratories to inspection, surveillance, audit, verification and calibration — all the services the Pharmaceuticals supply chain needs are under one roof.
All services
Standards
Standards referenced by the sector
Content is linked to standards based on the product's intended use, target market and technical characteristics.
- ISO 14644clean rooms and related controlled environments
- ISO 4802Hydrolytic resistance of the inner surface of glass containers
- ISO 719Water resistance on glass at 98 degrees
- ISO 720hydrolytic resistance in glass at 121 degrees
- USP <1225>Validation of compendial methods
- USP <231>heavy metals (classical method)
- USP <232>limits on elemental impurities
- USP <233>Determination methods of elemental impurities
- USP <381>elastomeric caps (injectable products)
- USP <467>residual solvents
- USP <61>microbial enumeration tests
- USP <62>tests for specified microorganisms
- USP <661>plastic packaging systems and components
- USP <71>sterility testing on pharmaceutical products
- UN 38.3Transport safety tests on lithium batteries
- ISO 11607end product sterile barrier packaging
- ASTM D3985oxygen permeability (OTR)
- ASTM D4728random vibration in packaging
- ASTM D5276free fall test on packages
- ASTM D642compression testing of packages
- ASTM D999vibration testing on packaging
- ASTM F1249water vapor permeability (WVTR)
- ASTM F1980accelerated aging in packaging
- ASTM F88peeling resistance in sealing seam
- ISTApackaging transport performance test series
- ASTM D1434Gas permeability in plastic film and sheet
- ASTM D1709free falling dart impact resistance in plastic film
- ASTM D3330peel adhesion on pressure sensitive tape
- 16 CFR 1303lead in surface coatings
- ASTM D4236chronic health hazard labeling on art materials
- ASTM D5116Determination of organic emissions from indoor materials
- BS 6920Suitability of materials in contact with drinking water
- EN 12457leaching experiment in the characterization of waste
- EN 12472Nickel release after wear and corrosion in plated products
- EN 12619total gaseous organic carbon in flue gas
- EN 12873Effect of materials coming into contact with drinking water
- EN 13284Determination of dust in stationary source emissions
- EN 13432compostability and biodegradability of packaging
- EN 13650aqua regia extractable element in fertilizers
- EN 14181Quality assurance of automatic measurement systems for stationary source emissions
- EN 14789determination of oxygen in flue gas
- EN 14790determination of water vapor in flue gas
Certification
Documents that enable your product to reach the market
Global Market Access
Pharmaceuticals which market will you offer your product to?
Pharmaceuticals when offering products to different markets, technical legislation, tests, documents and conformity requirements may vary by country and region.
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