Batch Release Test

In accordance with OECD and other international regulatory requirements such as CIBRC, OCSPP, SANCO, ASTM, EPA, JMAFF, EMEA, etc., CEBIS USA offers comprehensive regulatory testing services for registration of agrochemicals and chemicals.

Pharmacopoeia standards are used by people and organisations engaged in pharmaceutical research, development, manufacture, and testing as publicly published, legally enforceable standards of quality for pharmaceutical products and their constituents. Regulatory bodies and producers employ these criteria to make sure that the products have the right identity, strength, quality, purity, and consistency.

The British Pharmacopoeia (BP) is an annual publication of quality standards for UK pharmaceuticals that supports and complements the licencing and inspection procedures of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The official pharmacopoeia of the United States is the United States Pharmacopoeia (USP), which is sometimes known as the USP-NF. All prescription, over-the-counter, and other healthcare goods sold in the US must adhere to the requirements outlined in the USP-NF. The official organisation responsible for India’s drug regulation is the Indian Pharmacopoeia Commission (IPC).

Additionally, the REACH Regulation adds a specific obligation for ecotoxicological and toxicological tests in Article 13(4). Since no other international standard has been determined to be similar as of yet, new tests of this kind must be performed as per the Good Laboratory Practise (GLP) guidelines outlined in Directive 2004/10/EC as of June 1, 2008. It may be preferable but is not required to perform physical and chemical tests in accordance with GLP standards.

Before conducting new tests, one should refer to the Guidance on Information Requirements and Chemical Safety Assessment, which offers particular Integrated Testing Strategies for each endpoint (such as for aquatic toxicity, mutagenicity, etc.).

To gain clearance from the CIB (Central Insecticide Board), Ministry of Agriculture, Government of India for import, production, sale, or export, as the case may be, a test battery made up of analytical, ecotoxicity, in vivo, and in vitro toxicology studies is necessary. The Insecticides Act has specified standards for each end use.

According to the applicable pharmacopoeia, CEBIS USA provides the following services required for batch release pharmaceutical quality control:

  • Pyrogen testing
  • Stability studies
  • Profiling of abnormal toxicity and impurities

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