1. What types of testing does RMA provide?
RMA offers both compendial and non-compendial testing, including identity, purity, potency/assay, impurity analysis, and contaminant testing to support raw material qualification and finished product verification.
2. What is compendial testing?
Compendial testing follows established global pharmacopeia standards (e.g., USP, EP, JP, BP, ChP, ACS) to ensure regulatory compliance for raw materials, intermediates, finished products.
3. What is non-compendial testing?
Non-compendial testing refers to client-specific analytical methods tailored to unique product attributes or specifications that are not covered by pharmacopeial monographs.
4. What is the purpose of raw material testing?
Raw material testing ensures that incoming materials meet predefined specifications for identity, purity, strength, and quality before use in manufacturing. This prevents contamination, variability, and non-compliant finished products.
5. What tests are typically performed on pharmaceutical raw materials?
Common tests include:
Identification (ID) – FTIR, HPLC, GC
Assay (potency/content) – HPLC, Titration, UV
Impurities – Related substances (HPLC/GC)
Residual solvents – GC (USP <467>)
Elemental impurities – ICP-MS (USP <232>/<233>)
Microbial limits – USP <61>, <62>
Water content – Karl Fischer
Loss on drying (LOD)
pH, viscosity, density etc.
6. What is the purpose of finishing product testing?
Finished product testing confirms that the product meets approved specifications for Safety, Efficacy, Quality, Stability, Regulatory compliance.
7. What tests are typically performed on finished products?
Finished product testing in pharmaceuticals is performed to ensure that each batch meets its approved specifications prior to release, in compliance with 21 CFR Part 211 and relevant USP and ICH guidelines. Depending on the dosage form, testing may include, for solid oral dosage forms (SODFs), Assay, Content Uniformity (USP <905>), Dissolution (USP <711>), Related Substances, Hardness, Friability (USP <1216>), Disintegration (USP <701>), and Moisture Content etc. while for injectables, it may include Sterility (USP <71>), Bacterial Endotoxins (USP <85>), Particulate Matter (USP <788>), pH, and other relevant tests.
8. What is the difference between assay and content uniformity?
Assay measures the average drug content of a batch, while content uniformity evaluates variability between individual units.
9. Why is dissolution testing important?
Dissolution predicts in vivo drug release performance and ensures batch-to-batch consistency. It is a critical quality attribute (CQA).
10. When is stability testing required?
Stability testing is required for new product development, for shelf-life assignment, after formulation changes, for packaging changes, for regulatory submissions. ICH Q1A guidelines apply.
11. Can RMA help with analytical method development and lifecycle management?
Yes – RMA offers method services including feasibility studies, method development, and method validation aligned with ICH Q2 expectations, ensuring robust and scientifically sound analytical methods.
12. What is method validation, and why is it important?
Method validation confirms that an analytical procedure is fit for its intended purpose, that it produces accurate, precise, and reproducible results, supporting regulatory submissions and product quality decisions.
13. Does RMA run/support stability studies?
Yes, RMA supports comprehensive stability programs (long-term, accelerated, and photostability) designed to meet ICH requirements and support product development or commercial supply.
