GMP and cGMP as per USFDA
GMP and cGMP Certification Consultants
Good manufacturing practice (GMP) and cGMP (Current Good Manufacturing Practices) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines and USFDA quality assurance guidelines.
Pharmaceuticals, Bulk drug API manufactures, Formulation and Food Processors can certify for GMP certification and cGMP Certification as per USFDA and WHO guidelines.
How addwise can help you
addwise being USFDA FSPCA Approved PCQI (Preventive Control Qualified Individual) USFDA FSPCA PCQI-2017 can assess your current manufacturing facility and documentation whether meeting FSMA compliance requirements as per 21CFR.
addwise can help consult and assist in preparing to comply with USFDA FSMA requirements for your food products. addwise being USFDA FSPCA Approved PCQI (Preventive Control Qualified Individual) USFDA FSPCA PCQI-2017 can certify and approve your existing Food Safety Management System Plan to submit to USFDA.
addwise can help you prepare for USFDA Registration, USFDA Inspection, FSMA Compliance and USFDA FSVP audits from USFDA by advising on infrastructure modifications, preparing customised documentation of your product/ process to meet USFDA Registration USFDA Inspection requirements and help implementing USFDA Inspection requirements through hand holding and trainings.
should you need more details please get in touch with us on email@example.com or call us on +919978940673 – Girish Sharma.
Get one stop solution for any certification, compliance, advisory and training on FSSAI, USFDA, ISO 22000, BRC Food, FSSC 22000, IFS, SQF, HALAL, KOSHER, SEDEX certifications. Write to us on firstname.lastname@example.org or call us on +919978940673 – Girish Sharma.
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