GXP Analytical Method Development, Validation and Transfer

Cormica provides an unrivalled breadth of analytical solutions, techniques and applications to the pharmaceuticals, medical device, healthcare, agrochemicals, biocides, food and feed sectors, including pesticides. We specialise in the development, validation and deployment of highly sensitive robust analytical methods for the Occupational Hygiene (OH) monitoring of manufacturing and laboratory facilities.

Occupational Hygiene

Occupational Hygiene is the discipline of anticipating, recognising, evaluating and controlling health hazards in the working environment with the objective of protecting worker health and well-being. In practice, this means regular monitoring of active ingredients, relevant inactive ingredients, and surrogates via air filter sampling and surface swabbing, and analysis against agreed exposure limits using validated analytical methods.

Our holistic OH package includes the development and validation of analytical methods for multiple active ingredient types (hormones, cytotoxics, antibiotics, controlled drug substances):

  • Support in OH risk assessment, limit setting, sampling / testing protocols · Sensitive uHPLC-MS/MS methods to meet the growing demand for particularly challenging OEL / Reporting Limits
  • Preparation and supply of media (swabs, filters, pre-loaded IOM cassettes); training of staff in sampling
  • Routine analysis of samples to fast turnaround times
  • Analytical method development, validation and testing of proprietary APIs as well as surrogate AI materials such as lactose, mannitol and naproxen sodium

GLP / GMP Occupational Hygiene Accredited Laboratories

All work is performed within our MHRA & FDA-inspected, GLP / GMP accredited laboratories.

Our OH activities complement a range of other manufacturing support services to the pharmaceutical, healthcare, agrochemicals industries including raw material and batch release testing, Out of Specification investigations, ICH stability and cleaning validation / verification.

Our long history in pharmaceutical R&D and manufacturing support has resulted in over 500 validated HPLC methods for pharmaceutical actives.

Applications

Validated / verified methods can be transferred to the customer or a third party or can be utilised in-house at Cormica for:

  • QC Batch Release Testing
  • QC Reference Substance Qualification
  • ICH stability studies
  • GLP 5 Batch analysis 
  • GLP storage stability 
  • Regulatory submissions
  • Cleaning validation / verification 
  • Occupational hygiene
  • Plus many others

Capabilities

  • Method development, establishment, verification, and validation to GMP and GLP
  • Method transfer to and from customer laboratories, Third party transfers
  • Quantitative methods / Limit tests / Qualitative methods
  • Assay, Impurities, Physical properties,
  • API, Excipients, Raw materials, Formulations, Finished Products, Packaging
  • Compliance with ICH Q2 (R1), SANCO 3030/99 Rev 5, other relevant Regulatory guidelines, Pharmacopoeial methods, plus internal SOPs
  • Wide range of analytical techniques:
    • Separation sciences
    • Specialised, high-end product characterisation
    • Elemental analysis, Physico-chemical testing, Raw materials methods, Physical properties
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