Quality and compliance add
value to any organization and ensure the safety of medicines. For small companies, staying abreast of the
changing regulatory landscape and understanding current compliance standards
can be overwhelming. Additionally, with
the industry trend to out-source work to Asia, the need to monitor compliance
is increasing as there is inherently less control due to larger distances. CapEval Pharma consultants can give you peace
of mind and help assure the regulatory compliance and
quality of your medicinal products, tests, and studies.
We bring specific expertise in the following
areas:
- Development of policies, work instructions and specifications to meet
GMP requirements, including the latest FDA, Pharmacopeia and EMA guideline
- Preparation of quality agreements
- Review and approval of change control, deviations, corrective/preventative
actions and out-of-specification documentation
- Preparation and review of GMP documentation, including master production
records, batch records, testing records, stability protocols and reports,
development reports, and SOPs
- Assure GMP compliance of API manufacture for clinical or commercial
material
- Preparation and review of validation protocols and reports
- Work with in-house QA to improve existing quality systems
- GMP, IPEC, and ISO audits
- API and drug product manufacturers
- Testing laboratories
- Excipient and
raw material suppliers
- General quality systems audits, audit for cause or lot
specific audits
- Audits of contract facilities for supplier selection or
GMP compliance
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