We provide a full range of pharmaceutical product testing services for completed products for both domestic and export markets.
Our scientists are experienced, and our facilities are well-equipped to perform analyses in accordance with pharmacopeia monographs as well as client demands.
Our services cover identification, purity, and functional testing for sterile and non-sterile dosage forms such as tablets, capsules, syrups, dry syrups, suspensions, suppositories, pessaries, eye drops, ointments, transdermal patches, small volume parenteral, and large volume parenteral, among others.
In addition to regular analysis and release testing, our laboratories conduct stability studies, analytical method development, and validation studies to assist you with product development and registration in both semi-regulated and highly regulated markets.
Analytical method validation reports are required for the approval of pharmaceutical goods and pharmaceutical ingredients and are included in product dossiers.
All nations now require analytical technique validation reports with entire chromatograms and raw data to be provided with product dossiers for evaluation and approval.
Method validation is described as the creation of written evidence that proves the method’s fitness for its intended purpose.
A number of parameters must be created as part of the method validation process and must meet the worldwide acceptance criteria outlined in the ICH guidelines and the various pharmacopeias.
Method Validation provides a sure-fire technique of verifying that the chosen approach produces findings that are reproducible, reliable, and consistent.
As a result, it must also be ensured that the procedure to be used is completely defined.
We identify two sorts of techniques that need to be validated among the method validation protocols: pharmacopeia and non-pharmacopeia.
Pharmacopeia methods are evaluated and tested in several pharmaceutical products testing laboratories before being published, and they are anticipated to operate flawlessly in any laboratory.
Even if such procedures are utilized, they must first be properly examined to see if they can adapt to being frequently used in the laboratory for the specific product being analyzed.
The simple rule with such methods is that they must be appropriately validated.
Validation is essential in the pharmaceutical products testing laboratory to guarantee that they are appropriate for the analysis being performed.
There are a few common principles or criteria that can be followed for fruitful execution in this regard.
For items and materials, a clear delineation and requirements must be established. Every test must be documented in the standard test methods documentation.
In the case of pharmacopeia techniques and non-pharmacopeia methods, the standard test procedures to be utilized must be in conformity with the requirements given by regulatory organizations.
The validation of the study must include clear reference information that is concisely written.
All pharmaceutical businesses must constantly develop analytical methods for novel active pharmaceutical components, drug products, fixed-dose combinations, and excipients.
It is necessary for new product development and routine quality control, as well as regulatory submissions, stability studies, cleaning validation studies, and analysis of associated compounds and contaminants.
Stability testing is essential in the development of new pharmaceutical products and active medicinal components in order to determine their shelf life or expiration date.
Along with ongoing normal manufacturing, it is also critical to assess product quality as a function of time.
Product Shelf Life Assessment
Changeover and development of packing materials
Critical supplier change for product registration in global markets
Raw Materials Testing is a subcategory of Pharmaceutical Testing.
The examination of raw materials is critical for ensuring the safety, quality, and efficacy of pharmaceutical products.
Many factors, such as polymorphism, the particle size of raw materials, and other qualities, must be addressed when determining how raw materials should be mixed.
As a result, raw material analysis is required to establish the purity, identity, and quality of raw materials before they are used in the manufacturing process.
Before a pharmaceutical product or medical device is released for public use or sale, it must be approved by the State FDA and the Central Drugs Standards Control Organization (CDSCO).
Material analysis, DSC analysis, chemical tests, physical characterization, NMR testing, FTIR testing, and other procedures can be carried out by testing laboratories in accordance with the specifications and safety protocols provided by the FDA and CDSCO.
Chemical testing laboratories have traditionally performed raw material testing and prepared reports to verify their quality and appropriateness for use in pharmaceutical medication formulations. They are well-equipped to carry out the complex procedures required for raw material testing.
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