Throughout the drug development life cycle - from development to batch release - quality control testing of raw materials, excipients, containers, and packaging is critical. Controlling the quality of these materials is key to ensuring the safety, efficacy, and integrity of small and large molecule drugs.
Drug developers can effectively control the quality of raw materials and excipients used during drug development and manufacturing by implementing a raw material qualification program supported by a consultative contract research organization (CRO) and contract development and manufacturing organization (CDMO). Robust quality control programs, which include raw material qualification, pharmaceutical excipient testing, and packaging and container testing, ensure drug products are safe, efficacious, and suitable for their intended use. Furthermore, pharmaceutical raw material testing is a regulatory requirement, detailed within several guidance documents which various regulatory agencies have issued, including the US Food and Drug Administration (FDA), International Council on Harmonization (ICH), and the International Organization for Standardization (ISO).
Element’s teams of regulatory and scientific experts stay up to date with regulatory standards and guidance and have deep experience testing to ICH guidelines for excipients, including ICH Q8, ICH Q9, and ICH Q10, as well as ICH Q6A/Q6B specifications for raw materials, and routinely deliver results that comply with FDA requirements for excipients. Our extensive experience testing pharmaceutical raw materials, intermediates, excipients, key starting materials (KSM), finished products, containers, and packaging extends beyond pharmacopeial (USP, EP/Ph. Eur., BP, and JP) and compendial methods, and includes method development, verification, and validation, as well as analytical method optimization.
Comprehensive raw material, excipient, and container QC and testing services
Pharmaceutical raw material release – The criteria detailed within 21 CFR 211.84 must be met before any raw material can be used within any pharmaceutical manufacturing process or formulation. Ensure materials meet established raw material specifications for pharmaceuticals with Element’s complete raw material release testing services. Our experienced scientists use a wide range of advanced analytical techniques and instrumentation to confirm the identity and integrity of raw materials.
Raw material testing for biologics – Leading biotechnology and biopharmaceutical organizations partner with Element to fill gaps, increase efficiency, and to help drive research and development as well as commercialization. This includes testing of starting materials and source materials, such as cell substrates, tissues, and biological materials used for cell growth, propagation, differentiation and selection, to established raw material testing guidelines for biotechnical and biological products, including ICH 6QB.
In-process quality control (IPQC) testing – Element’s full complement of quality control (QC) and release testing services includes in-process testing and process validation testing. Our in-process QC testing programs help to ensure established product critical quality attributes (CQAs) are met during production and manufacturing and can also provide critical information to inform the optimization of manufacturing processes and procedures.
GMP material and lot release – Our extensive cGMP material and lot release testing service offerings extend from analytical method development, validation, qualification, and transfer to physical and chemical analyses, including identity, potency and purity, and residual solvent testing. This is accompanied by a complete selection of microbiology tests and assays, as well as endotoxin testing.
Pharmaceutical batch and lot release – Element’s chemistry, manufacturing, and controls (CMC) experts tailor comprehensive QC lot release testing programs to the needs and specifications of each unique pharmaceutical product tested. Compendial and pharmacopeial methods are followed when applicable, and our teams of regulatory and scientific experts develop and validate new analytical methods when needed. We also offer transfer, verification, and optimization of existing methods.
Biologics batch and lot release – The purity, concentration, consistency, identity, and biosafety of biological products must be verified before they can be released for use. Element’s consultative, experienced scientists can develop and carry out a biological product material and release testing program for your biologic therapy that meets regulatory requirements.
Compendial monograph and pharmacopeial testing – Compendial testing programs meet specifications set forth in USP/NF, Ph. Eur./EP, BP, and JP. Pharmacopeial methods are used to qualify raw materials, excipients, intermediates, active pharmaceutical ingredients (APIs), starting materials, cell banks, vectors, bulk harvest materials and control cells. When compendial methods are not available, non-compendial analytical methods can be developed and validated to cGMP standards of 21 CFR 210 and CFR 211. In addition to a complete offering of compendial testing for pharmaceuticals and biologics, a range of compendial microbiology services are available.
Pharmaceutical container and packaging analysis – Determine the suitability of pharmaceutical containers and packaging for its intended use, including plastic bottles, glass vials, stoppers, container-closures, rubber, and plastic materials. We test to a wide range of compendial methods, including USP, Ph.Eur./EP, and JP. Element’s thorough container and packaging testing services ensure packaging does not have an effect on the identity, safety, quality, purity, or strength of drug products. Furthermore, Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.
The Element advantage
Ensure the integrity, safety, quality, and purity of small and large molecule drugs with Element’s flexible and comprehensive testing quality control testing programs for raw materials, excipients, and containers tailored to the needs of each unique drug product and therapeutic. Avoid costly delays and overcome challenges with the support of Element’s engaged, consultative team of regulatory and scientific experts.
To learn about our customized approach to controlling the quality of raw materials, excipients, pharmaceutical containers and packaging, or to speak with one of our experts, contact us today.
More from Element
Pharmaceutical Container and Packaging Testing
We provide professional testing services for containers, container closures and pharmaceutical packaging on polymers and glass containers to several pharmacopeia methods, including USP, EP, and JP methods.
Pharmaceutical Raw Material and Finished Product Testing
Our raw material and finished product testing bring peace of mind to manufacturers of drug products ensuring the safety, purity, and quality of both starting materials and manufactured products.
ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.