GMP COMPLIANCE FUNCTIONS:
Acute Research is a fastest growing GMP Compliance solutions provider globally, unique in terms of holistic GMP compliance offering of consulting and outsourcing solutions.
Acute Research is highly specialized with different Centre of Excellence for various GMP Compliance functions
GMP Compliance Strategy and Consulting
- Acute Research assists to provide strategy and action plan to facilitate the regulatory audits like USFDA, EUGMP, TGA etc.
- To coordinate with regulatory agencies to collate of supporting documents required by regulatory agencies to process the audits, co-ordination for fees etc.
- Hold interaction with regulatory agencies on behalf of clients companies.
- Preparing the cover letter, application form as per clients request.
Gap analysis vs Practices
- Acute Team has expertise to find out the gaps vs practices in QMS documentation.
Remedial measures on gap analysis
- Acute Team has expertise to provide remedial measures on the gaps findings and implementation of various system
Facility audits
- Acute team has expertise to audits the facility as per regulatory norms 21 CFR 211, 210, EU GMP, ICH Q7 etc.
Implementation of various policies and committees
- Acute support to implement various important policies to support system deficiencies. Also assist to implement the policy on global CAPA in various facilities as an unique quality system.
- Acute support to form various committees like ‘remediation measures monitoring committee, ‘a GMP resource advisory committee’ committee to monitor preventive maintenance programme activity and formation of GMP Compliance cell to monitor all activities related to GMP.
Intensive Training Programme on cGMP
- Acute has expertise team to identify and conduct the GMP training as well as subject related training on continuous basis as the most important tool to overcome the GMP issues.
Product Risk Assessment & Global CAPA
- Acute team assists to conduct the product risk assessment based on previous findings from the regulatory authorities. This will involve retrospective review of product quality data, manufacturing data, deviations, change control, out of specification (OOS), stability data and market complaints for last two years.
- Acute assist to write Global CAPA and implement of the same in all manufacturing sites.
21 CFR compliance activities
- We assist in 21 CFR compliant network software for chromatographic instruments and training of laboratory staff.
- Installation and validation of 21 CFR part 11 compliant network software for all chromatographic instruments, this will help to archive the electronic data on a real time basis.
We provides end to end regulatory services for US, EU, Canada, India , Latin America , Asia , Middle East and other emerging markets.