Finished Product Testing is a High Priority for Pharmaceutical Industry
It is the Pharmacopoeias that set standards for desired quality of pharmaceuticals and pharmaceutical testing laboratories authenticate that the pharmaceutical finished product has attained the quality control requirement. The finished products like tablets, capsules, syrups, dry syrups, suspensions, suppositories, pessaries, eye-drops, ointments, transdermal patches, small and large volume parenterals etc. must satisfy the standards for purity, safety, efficacy, stability, potency, patient acceptability as well as regulatory compliance. Pharmaceutical testing labs carry out testing for all these parameters so the pharmaceutical release is smooth.
Pharmaceutical testing begins right at the developmental and formulation stage so that the physical, chemical and biological specifications fulfil all quality requirements for pharmacopeia standards. Pharmaceutical testing laboratories also carry out in-process testing because that determines the outcome in the finished product. During in-process pharmaceutical testing the product is monitored and adjustments are made in the formulation or process so that the finished product does not have errors. Only after in-process quality control testing is complete, then on manufacturing the finished product, it is tested for all pharmacopeia specifications.
The pharmaceutical industry also sends samples for third party pharmaceutical testing because they want to ensure that the finished products is perfect before it is released in the market. Recognised pharmaceutical laboratories are well equipped and experienced in carrying out the analysis as per pharmacopoeia monographs and also in accordance with specifications given by the clients. Pharmaceutical testing laboratories carry out important finished product tests like the following
- Description where they ensure that the appearance of finished product like tablets is in accordance with specifications like white, coated, round, etc.
- Identification testing verifies the identity of the active pharmaceutical ingredient (API) so as to distinguish it from other similar compounds
- Assay testing determines the strength of the API
- Impurities testing determine that there is no other substance in the pharmaceutical than API and excipients
- Content uniformity testing ensures that every dosage contains the same and equal amount of drug substance API within a batch
- Weight variation between tablets with respect to dose and weight must be reduced to a minimum so there is consistency in dosage
- Friabilitytesting is used to ascertain the durability of tablets during transit, so they can withstand breaking or chipping
- Hardness testing is required to measure the time a tablet will take to disintegrate or dissolve
- dissolution testingis required to check the dissolution rate and effective absorption of dosage from tablets or capsule once consumed
The pharmaceutical tests mentioned above are just a few of the important parameters that pharmaceutical laboratories test for. Pharmaceutical finished product testing laboratories are well equipped and have the technical know-how to carry out all analysis according to pharmacopoeia requirements or specifications given by clients. To ensure consistent high standards in the finished product the pharmaceutical industry selects independent pharmaceutical testing labs to perform product release testing. This is an important parameter prior to the market release of the pharmaceutical for sale or export as it indicates that the pharmaceutical has fulfilled the requirements of pharmacopeia monographs.