Sharp has become the “gold standard” with respect to inspections by the US Food & Drug Administration (FDA), European Medicines Agency (EMEA) and Drug Enforcement Agency (DEA). Our strict compliance with industry procedures and audits provides our customers with the assurance that your contract packaging needs will be completed properly and within specifications .
Quality Control
- Facilities are cGMP compliant
- Compliance with 21 CFR, Parts 210 & 211 for storage, processing and packaging of various products
- ISO 13485:2003 (Medical Device) – Certified 02/2009
- ISO 9001:2008 (Drug Packaging) – Certified 07/2009 / Re-Certified – 05/2011
- Full validation program
- Master validation plan
- Equipment IQ, OQ, PQ and PV
- Incoming material / component testing
- cGMP / GMP personnel training program
- Integrated and systematic change control procedure
- In-process quality assurance verifications
- Validated equipment parts cleaning system
- Customer specified record retention
- Corrective and Preventative Action (CAPA) program
Quality is built into every step in our operation. This core value is the cornerstone of Sharp.
