Excipients raw materials and Container testing

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Collaborating with a consultative contract development and manufacturing organization (CDMO) and contract based research organization (CRO) can aid drug manufacturers in effectively managing the excipients used and quality of the drug development process. Through processes such as pharmaceutical excipient testing, packaging and container testing, and raw material qualification, drug products can be ensured to be safe, effective, and suitable for their intended purpose. Various regulatory bodies, such as the FDA, ICH, and ISO, have established guidelines outlining the regulatory requirements for testing pharmaceutical raw materials. MedWatch Global has extensive experience testing to these guidelines, including method verification, development and validation, as well as analytical method optimization, ensuring compliance with FDA requirements for excipients. In addition to compendial methods, they have experience testing pharmaceutical raw materials, intermediates, excipients, key starting materials (KSM), packaging, containers and finished products. Other regulatory bodies that have done the same include the US international council on harmonization (ICH), Food and Drug Administration (FDA), and International Organization for Standardization (ISO).  ICH Q6A/Q6B ICH Q8, ICH Q9, and ICH Q10, as well as specifications for raw materials, MedWatch Global’s teams of regulatory and scientific experts regularly deliver results that are in compliance with FDA requirements for excipients. Beyond pharmacopoeia (USP, BP) and compendial methods, our extensive experience testing pharmaceutical raw materials, intermediates, excipients, key starting materials (KSM), containers, finished products and packaging includes method development, validation and verification as well as analytical method optimization.

 Testing Services and Comprehensive QC for raw materials, excipients, and containers:

Pharmaceutical raw material release – Any raw material used in the production or formulation of pharmaceuticals must first satisfy the aforementioned requirements. The thorough raw material release testing services offered by MedWatch Global can help you make sure that materials match the stipulated raw material requirements for pharmaceuticals. Our competent personnel verify the veracity and integrity of raw materials by using a variety of cutting-edge analytical techniques and equipment.

Biological examination of raw materials -Collaborating with MedWatch Global enables leading biotechnology and biopharmaceutical companies to bridge market gaps, enhance productivity, and advance research and commercialization efforts. To achieve this, it is essential to test starting materials and source materials against recognized raw materials, such as biological components, tissues, and cell substrates utilized in cell growth, differentiation, division, and selection.

In-process testing and process validation

MedWatch Global offers comprehensive release testing services and quality control, which include in-process QC testing. This testing program plays a vital role in ensuring that product critical quality attributes (CQAs) are met throughout the manufacturing and production processes. In addition to ensuring compliance, it also provides essential information that can aid in the optimization of manufacturing processes and procedures.

GMP material and lot release – The invention, qualification , validation and transfer of analytical methods as well as physical and chemical analyses consists of  identification, purity and potency, and residual solvent testing are just a few of the many cGMP material and lot release testing services that we offer. This includes testing for endotoxins as well as a wide variety of microbiology assays and tests.

Release of biologics by batch and lot – Pharmaceutical batch and lot release: The chemistry, manufacturing, and controls (CMC) experts at MedWatch Global create extensive QC lot release testing programmes to match the demands and specifications of each unique pharmaceutical product evaluated. When necessary, pharmacopeial and compendial methods are utilized; in the absence of these, our teams of regulatory and scientific experts develop and assess novel analytical techniques. Additionally, we transfer the transfer, validation, and the advancement of already existing methods. Establishing the biosafety, purity, and identification of biological products is necessary before making them available for use. The knowledgeable and experienced scientists at MedWatch Global can assist in creating and implementing a regulatory-compliant testing program for biological product material and release. This program can help ensure the quality and safety of your biologic medicine.

Pharmacopeial and compendial testing

MedWatch Global’s testing programs for compendial testing adhere to the guidelines set forth by USP/NF, BP. These programs utilize pharmacopeial processes to qualify a variety of materials, including intermediates, excipients, intermediates, active pharmaceutical ingredients (APIs), vectors, starting materials, banks, bulk harvest materials, and control cells. If compendial methods are unavailable then non compendial methods are developed and validated to comply with cGMP standards, specifically those outlined in 21 CFR 211 and CFE 210. In addition to a comprehensive range of compendial testing for pharmaceuticals and biologics, MedWatch Global also offers a variety of compendial microbiological services.

Pharmaceutical packaging and container  analysis– The suitability of pharmaceutical packaging and containers, including glass, plastic, rubber, stoppers, and container-closures, for their intended use is evaluated by MedWatch Global. The testing is carried out using a range of compendial methods such as USP. The extensive container and package testing services provided by MedWatch Global ensure that the packaging does not compromise the identification, safety, quality, purity, or potency of drug products. Additionally, MedWatch Global’s extractables and leachables (E&L) practices are among the most experienced and comprehensive in the world.