Quality Assurance and Compliance
♦ New facility design and construction
- We will provide service for the new facility construction for Solid orals (tablets, capsules, powder for orals).
- Liquid orals (suspensions, emulsion, clear liquids, syrups, oral drops) / external application liniments / lotions.
- Soft gelatin capsules.
- Oncology facility.
- API manufacturing facility.
♦ GMP audit
- Performing facility audits, system audits, system establishments, procedures review and guidance to suit the manufacturing facility in accordance to guidelines of all Major Health ministries (US FDA, EU, UKMHRA, Health Canada, TGA Australia, Cofepris, ANVISA, INVIMA, SAHPRA, Etc.).
- Supplier audit, self-inspections.
♦ Failure investigation
- Review of inventions like, OOS, Market complaints, Incidents, OOT, OOC, deviations and CAPA,
- Risk assessment.
- Any product failure investigation
♦ Regular actions Remediation
- FDA warning letter.
- EU / Health Canada.
- WHO actions.
♦ GMP / GDP/ GLP trainings
- People training on Regulatory requirements / basics of GMP/GDP/GLP.
- People development.
♦ Validation support
- Protocol driven support for the followings.
- Process validation.
- Cleaning validation.
- Analytical method validations.
♦ Facility qualification support
- Protocol driven support vigorously the following.
- IQ, OQ, PQ and software systems.
- Facility related risk assessment.
♦ Regular audit points response
- Response to global regulatory audit observations (US FDA, EU, UKMHRA, Health Canada, TGA Australia, Cofepris, ANVISA, INVIMA, SAHPRA, Etc.).