Pharmaceutical Products Testing
ATRL is the standard for quality and excellence and our knowledge and experience enable us to provide assistance to the ongoing operations of pharmaceutical companies & medical device manufacturers.
ATRL is your partner in quality control, research and development and method validation. ATRL is a true independent laboratory that you can trust. Our services and capabilities range from complex analytical testing and methods development to product release testing, method validation, stability testing, quality control and compound identification.
The pharmaceutical industry uses a very large variety of raw materials and literally hundreds of ingredients can go into the manufacturing of a single product. Any pharmaceutical product manufacturer, requires a quality control which is one of the foremost requisite with regard to regulatory compliances.
ATRL has expertise in field of Pharmaceutical testing & research.
We provide a full range of pharmaceutical product testing services for completed products for both domestic and export markets.
ATRL Perform test on following items.
1. Injections
2. Tablets
3. Capsule
4. Syrup
5. Ointment
6. Drops
7. Powder pack
8. Raw Materials
Pharma Method Development
Method Validation:
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.
The method validation study has two main objectives:
- With the acceptance criteria in mind, comprehensive testing must be performed to assure and guarantee a particular level of consistency.
- After determining the operational limits, variables must be evaluated based on their impact on the testing process
Protocols for Method Validation
We identify two sorts of techniques that need to be validated among the method validation protocols: pharmacopeia and non-pharmacopeia.
Pharmacopoeia Procedures:
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.
Non-pharmacopoeia Procedures:
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.
Method Development:
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:
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.
Testing of Raw Materials
Raw Materials Testing is a subcategory of Pharmaceutical Testing.Quality of raw materials effect the quality of finish product.