Product identity and authorisation
- Active substance / active ingredient
- The component intended to provide the pharmacological activity of a medicine. The exact salt, ester or other form can matter to product identity.
- Dosage form
- The physical pharmaceutical presentation, such as tablet, capsule, solution, suspension, cream or powder for preparation.
- Strength
- The amount or concentration of active substance expressed with its complete unit and basis, such as per tablet, per millilitre or per actuation.
- Marketing authorisation / product registration
- A competent authority’s permission for a specific product within its legal framework and approved conditions. It is not inferred from a generic name or another country’s approval.
- Authorisation holder
- The legal entity that holds the relevant product authorisation in the jurisdiction concerned.
- Pharmaceutical equivalent
- A regulatory comparison term for products that meet specified sameness criteria for active ingredient, dosage form, route, strength and quality. Exact definitions depend on the authority.
- Therapeutic equivalence / interchangeability
- A product-specific regulatory conclusion requiring defined evidence; not a synonym for sharing an ingredient.
Quality and manufacturing
- GMP
- Good manufacturing practice: requirements and systems intended to ensure medicines are consistently produced and controlled to appropriate quality standards.
- Manufacturing authorisation
- Authority to conduct specified manufacturing activities at a defined site and scope under applicable law.
- Specification
- Defined tests, analytical procedures or references and acceptance criteria used to assess the quality of a material or product.
- Certificate of analysis (CoA)
- A batch- or sample-specific analytical report showing identity, methods or specifications, results, acceptance criteria and an authorised conclusion.
- Pharmacopoeia
- An official or recognised compendium of pharmaceutical quality standards, monographs and general analytical texts.
- Reference substance / reference standard
- A characterised material used as a comparison or calibration standard in specified analytical procedures.
- Qualification
- Documented evidence that premises, systems or equipment are installed and operate as intended within a defined scope.
- Validation
- Documented evidence that a process, method or system consistently performs as intended for its defined purpose.
Sterile manufacturing and handling
- Aseptic processing
- Manufacturing in which sterile product, containers or components are handled and assembled under controlled conditions intended to prevent microbial contamination.
- Terminal sterilisation
- Sterilisation of a product in its final container or final assembled state using a validated process suitable for that product and package.
- Contamination-control strategy
- A planned system connecting facility, process, personnel, monitoring and quality controls used to prevent and detect contamination risks.
- Stability
- Evidence describing how product quality changes over time under defined conditions and supporting shelf life and storage statements.
- Temperature excursion
- A departure from defined storage or transport conditions that requires product- and event-specific assessment.
Safety and quality concerns
- Adverse event
- An unfavourable medical occurrence associated in time with use of a product; the term does not by itself prove causation.
- Pharmacovigilance
- Activities for detecting, assessing, understanding and preventing adverse effects or other medicine-related problems.
- Product-quality complaint
- A report of a suspected defect or problem involving identity, packaging, labelling, appearance, performance, storage or another quality attribute.
- Substandard medical product
- A WHO term for an authorised medical product that fails to meet quality standards or specifications.
- Falsified medical product
- A WHO term for a product that deliberately or fraudulently misrepresents its identity, composition or source.
Devices and diagnostics
- Intended use
- The purpose for which a medical device or diagnostic is designed and labelled by the responsible manufacturer within the applicable regulatory framework.
- Instructions for use (IFU)
- Controlled instructions supplied for the exact device or diagnostic model, including use, warnings, handling and other information required by the applicable framework.
- Compatibility
- A product-specific relationship showing that components, consumables, devices or accessories are intended and supported for use together. It should not be inferred from generic similarity.
- Performance evaluation
- Evidence used to establish that a device or diagnostic performs as intended for its specified purpose. Requirements vary by device and jurisdiction.
How to use the glossary
These definitions help interpret this website. They do not replace statutory definitions, current regulatory guidance, approved labels, pharmacopoeias, contracts or controlled company procedures. Follow the linked substantive resource pages when a term affects a due-diligence decision.
Start with medicine identity, GMP and product approval, interchangeability and the reference directory for deeper context.
Sources and further reading
Source links and editorial scope checked 11 September 2026. External sources remain attributable to their issuers and do not establish Luang Pharma product or facility status.