Pharmaceutical Finished Product Testing GMP-Compliant

Why Finished Product Testing Is Essential for Regulatory Compliance

Comprehensive testing of pharmaceutical finished products requires the assessment of purity, potency, quality, uniformity, stability and much more.

These assessments are essential to ensure that every batch meets its specifications, complies with regulatory requirements, and is safe and effective for patient use. Without robust finished, GMP product testing, there is a risk of variability, reduced efficacy, and product recalls, all of which can impact patient safety and product integrity.

Types of Pharmaceutical Finished Product Testing Available

HMR Labs offers a wide scope of pharmaceutical finished product testing, incorporating a breadth of analytical technologies and techniques across chemical, physical and microbiological testing.

We undertake finished product testing on pharmaceutical products for a number of different purposes:

Supporting Batch Release, GMP Compliance and Custom Testing Programmes

HMR Labs’ collaborative pharmaceutical finished product testing services can support batch release requirements as well as ongoing batch record QA/QC, GMP assurance, regulatory compliance and fully validated, customised testing programs.

If you’re looking for a value-add provider of the most essential component involved in ensuring batch release integrity, safety and quality, work with us:

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cGMP testing and analysis

Testing conducted at a variety of drug development stages

Finished product testing submission and audit documentation

pharmaceutical finished product testing

Batch Release Testing

Pharmaceutical batch release testing can vary depending on the nature of the pharmaceutical product and the regulatory requirements of individual markets, however HMR Labs’ analytical and technical teams have the expertise and knowledge to conduct batch release testing in accordance with all internationally recognised compendial methods (e.g. Ph.Eur., BP, USP and JP) as well as custom validated release test methods.

Our GMP compliant analytical chemistry and microbiological testing laboratories house a range of state-of-the-art instrumentation. With innovative technologies available to meet the quality, safety and regulatory standards set for final product inspection.

From ICP mass spectrometry to chromatography, spectrophotometry and more, HMR Labs has expertise with even the most complex testing methods to ensure a streamlined pharmaceutical batch release program with MHRA, FDA and other regulatory body requirements.

Work with HMR Labs to establish your batch release testing timeframes, budget and requirements, and we will tailor your testing program to suit. Helping manufacturers globally to meet quality and safety analysis of finished products.

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Pharmaceutical finished product testing done in HMR Labs analytical testing laboratories.

Pharmaceutical Product Testing Quality Assurance Guarantee

Manage the quality assurance of your batch manufacturing through in-process finished product testing. This type of analysis, carried out in real time can help to ensure that finished pharmaceutical products are being manufactured to within the desired quality control specification and regulations.

HMR Labs own MHRA inspected laboratories. These provide in-depth quality control and in-process testing services. Highlighting manufacturing and supply chain quality improvements through finish product testing and analysis.

Access formulation assessment and evaluations which can provide valuable performance insight of specific batches prior to sale. Find out how our extensive experience with GMP testing can help assess your manufacturing processes.

Comparator Studies for Pharmaceutical Validation

HMR Labs are experienced with undertaking finished product testing to support comparative analysis testing for a wide range of formulations and finished product types.

This type of finished product testing helps customers understand whether a finished product is relative or superior to an existing product through comparator study. Alternatively, further pharmaceutical assessment can determine whether a product is equivalent in terms of in-vitro performance, including to a marketed therapeutic, validating comparative bio-equivalence. For IVBE studies, we also offer a fully compliant service in-line with international regulatory guidances.

Our comparator testing services also include stability storage and analysis, method development and validation, as well as an extensive range of product development and performance characterisation studies.