With our veteran and vibrant validation execution team, we are capable to provide a one-stop service for your plant from consulting to your validation systems, also assist your validation team to upgrade continuously so as to well accept for NMPA, FDA, EMA, PIC/s, TGA, WHO-PQ GMP inspections and inspections from other territories.
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01
Guiding for validation SOPs new drafting or upgrading as per customer’s internal GMP requirements and also with reference to NMPA, FDA, EMA, PIC/S and TGA guidelines.
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02
Suggestions for validation related key position set up and candidate qualifications according to the current and future developments needs of the pharma.
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03
Assist in formulating validation strategies based on risks assessment to ensure compliance with NMPA、FDA、EMA、PIC/s、TGA, WHO and other relevant regulations, as well as applicable for the pharma’s operation needs.
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04
Different level of supports: providing SOPs template, reviewing/formulating SOPs list, guiding customer to draft or drafting SOPs directly on behalf of customer.
Provide solutions for the full life cycle of the MAH system