Product and Facility Certification Support in India

The manufacturers that operate both domestically within India and internationally need to comply with the requirements of several regulatory authorities at the same time, such as BIS mandatory certification for compliance in the domestic market, CDSCO for pharmaceutical and medical devices, FSSAI for food products, and certifications for export destinations such as CE for the European Union, US FDA for the United States, and GCSO for Middle Eastern exports. Running certification programs individually causes redundancies in the process and conflicting deadlines as well as discrepancies between documents that result in extended certification process durations and higher costs. IMARC Engineering provides a certification process strategy that optimizes certification processes by sequencing domestic and export certifications for maximum compatibility, taking advantage of commonalities between requirements and documentation wherever possible.

Gap Assessments conducted based on facility and product compliance evaluation against quality system templates rather than the certification criteria of the target authority will yield erroneous findings, where there is identification of non-compliance gaps that do not fall under the scope of the assessment criteria of the target certification process while overlooking some non-compliance gaps which will yield findings during the actual certification. IMARC Engineering performs GAP Assessment before Certification using the criteria set out by the target authority such as the factory inspection criteria for obtaining the ISI mark from the Bureau of Indian Standards, CDSCO factory inspection criteria for a licence in pharmaceutical manufacture, WHO GMP criteria for export market certification, and certification body audit criteria for ISO certification.

Certification requests turned down or delayed due to documentation gaps such as lack of adequate technical files, improperly filed test reports, incomplete quality system files, and insufficient evidence of conformity to the standard are some of the more easily avoided causes for certification delays in India. IMARC Engineering prepares documentation for certifications in accordance with the format, content, and substantiation specifications demanded by the certification bodies being sought. Documentation for products seeking certification from BIS would be in keeping with the respective IS specification and requirements of BIS; those seeking license from CDSCO to manufacture would be prepared according to Schedule M and Form 27/28 requirements; CE marking technical files are in accordance with the European Directive/Regulation; and ISO certifications' audit documents conform to the certification body pre-certification requirements.

Product certifications in BIS, CE mark, CDSCO, and export markets would entail product testing at laboratories with the right scope of accreditation and any product testing done outside the laboratories meeting these criteria would not be considered even if technically valid, leading to the need to retest which leads to added expenses and delayed certifications. The managed testing services offered by IMARC Engineering would involve the coordination of testing procedures in laboratories that are accredited by NABL and other international bodies according to the scope of their accreditations for each type of certification and also considering the lead times for testing and geographic convenience in laboratory locations, while analysing reports for both technical accuracy and acceptability by the relevant certifying body and dealing with failures that involve redesigning or additional testing.

Technical questions from certification bodies may emanate from BIS product certification officials, CDSCO licensing officials, WHO GMP assessors, and ISO certification body auditors. It is critical to provide technically sound responses on time which should provide an answer to the technical questions raised based on documentary evidence and not on the initial stand in the application. Technical questions that do not show evidence of the initial compliance position taken results in further rounds of assessment, thus delaying certification process. IMARC Engineering will take care of all correspondence from certification bodies from application stage up to the point of awarding the certificate. This entails providing technical responses backed up with evidence and following up to obtain certification.

Product and facility certifications that have been successfully achieved without proper ongoing maintenance in the form of renewal, scope management for additions, notifying the certification body of changes to the certified product or facility, and compliance monitoring will lapse, become suspended due to non-compliance, or become voided due to unreported changes which result in scope violation of the certification. The IMARC Engineering team oversees ongoing certification maintenance with regards to keeping track of renewal dates, compiling and submitting renewal documents, applying for scope extensions as new products or facilities are added to the certified portfolio, submitting notifications regarding product and process changes to the certification body, and conducting periodic compliance reviews to prevent any compliance drift.