Prime health is an integrated solution providing full compliance with GMP, and 21 CFR part 11 guidelines, complies with International Standards and Quality Guidelines of ISO/IEC 17025, ISO 9001 (Quality Management System), ISO 14001 (Environmental Management), OHSAS 45001 (Occupational Health & Safety), ICH and WHO the against which the competence of testing and calibration laboratories is assessed. From the time your sample enters our laboratory to the time your report leaves our premises you are guaranteed service of high integrity.
Prime Health provides expertise in Quality Control Testing, Method Development, Validation, comparative dissolution and Stability Storage facility and Testing of pharmaceutical raw materials and finished products at state-of-the-art GMP complaint facility. Prime Health is providing independent, contract analytical services to the global pharmaceutical and related industries.
Pharmaceutical Equivalence Studies
Pharmaceutical equivalence studies (Comparative dissolution profile) is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. At Prime Health comparison of therapeutic performances of two medicinal products containing the same active substance will help assessing the possibility of alternative using between the innovator and any essentially similar medicinal product.
Raw Material Testing
Prime Health raw material testing will help provide purity, contamination, Residual Solvents and material testing services, for a variety of raw materials. Raw material quality control is necessary to prevent product failure and ensure a consistent level of quality, as well as safety in consumer and industrial products.
Stability studies
Stability testing (Using stability indicating methods) at Prime Health Lab will help to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability Storage is structured as multiple chambers, which are designed to meet various temperature conditions, required by FDA and ICH, as well as other conditions required specifically by the client. All of storage chambers are continuously monitored by a computerized system, with temperature and humidity set-point windows at ±2° C and ±5°RH.
Pharmaceutical Finished Product testing
Finished product testing will be performed as per guidelines by FDA. All finished products must be tested prior to distribution. The tests that are performed will ensure that the product meets established specifications and that these specifications account for its purity, integrity, efficacy, and concentration. The tests can include titrations, Spectrophotometer, pH, conductivity, HPLC, GC, AA, and others.