Regulatory Compliance (GMP, ISO, FDA, BIS) in India

Indian manufacturers requiring compliance for domestic market access, international market entry, and organizational purchase approval must meet compliance criteria under various regulatory bodies including CDSCO & Schedule M for pharmaceutical GMP compliance, WHO-GMP and US FDA for export markets, FSSAI for food manufacturing, BIS for mandatory product certifications, ISO 9001 & 13485 for quality management systems certification, as well as other sector-specific criteria built upon these foundation stones. Compliance to each of these bodies individually results in inconsistencies in documentation, duplication of auditing procedures, and inadequate certifications, leading not only to lack of market access but operational inefficiencies as well. IMARC Engineering incorporates multi-body compliance within its quality management systems by structuring the documentation process, training procedures, and operations according to the criteria of each body in such a way that no separate system is formed from the production reality.

Over 30% of Indian manufacturing plants are found to be lacking in compliance during the first regulatory inspections, deficiencies which go unnoticed due to the lack of systematic internal compliance review by employees who have been working inside the plant and therefore have become blind to the non-compliance issues that an experienced external auditor can spot right away. IMARC Engineering offers compliance gap assessment services based on the criteria that would be used by the target regulatory agency such as CDSCO's inspection checklists for Pharmaceutical GMP; WHO-GMP audit checklist for compliance with exports markets; US FDA 21 CFR Part 211 criteria for FDA-registered plants; and BIS product certification checklists for mandatory certification categories.

Inadequate documentation is the number one reason for compliance observations in India’s manufacturing sector. Not because Indian manufacturers do not have their documentation systems in place; the problem lies in the way that they are designed in terms of production convenience and not regulatory compliance needs. IMARC Engineering creates documentation systems based on regulatory documentation standards – SOPs reflecting actual practice and not just theoretical procedures, batch records reflecting critical quality attributes required by GMP, validation master documents adhering to the necessary standards and format, and quality system documentation proving the presence of an effective QMS. The strength of this documentation system keeps Indian manufacturers in compliance during inspections and external audits without scrambling last minute to document their processes and practices.

Process validation and equipment qualification are some of the most challenging compliance requirements for the pharmaceutical, food, and medical devices industries, involving the provision of IQ, OQ, and PQ documents demonstrating that processes and equipment used in the manufacture of the products consistently provide an output conforming to the specifications. Validation activities done without sufficient regulatory expertise will produce validation documents which pass internal scrutiny but fail external inspection because qualification activities do not cover the process critical to the regulatory authorities, whose validation they demand; acceptance criteria have no scientific basis; or statistical methods are not sufficiently sound enough to show process capability. IMARC Engineering develops validation and qualification activities that comply with ICH Q8, Q9, Q10, and Q11 standards for the pharmaceutical industry, GAMP 5 standards for computerized systems, and ISO 13485 for medical device production, resulting in validation documents capable of passing CDSCO, WHO, and USFDA scrutiny.

The best way to prepare for inspections and certification audits is through a stringent mock inspection carried out by competent external auditors using the exact same assessment guidelines as those used by the intended regulatory agency, with non-conformities being flagged in enough time to address them before the actual inspection takes place. IMARC Engineering provides mock inspection services based on the requirements of CDSCO, WHO-GMP, US FDA, EU GMP, FSSAI, BIS, and ISO certification audits. This includes an assessment of documentation accuracy and completeness, GMP compliance of the facility, quality management system adoption, training records, and data integrity. The results of the mock inspection are categorized according to their level of severity, corrective measures are planned, and a remediation program prior to the inspection is implemented.

Regulatory compliance is not an outcome of certification; it is a constant discipline which needs constant supervision by management, internal audits from time to time, and efforts towards continual improvement in maintaining the compliance status gained after the successful certification or inspection process. IMARC Engineering offers assistance for regulatory compliance maintenance through periodic internal auditing programs, CAPA system management, monitoring of regulatory changes and evaluating their implications for the existing quality systems, managing change control related to any facility or process or documentation changes, and management reviews. Such assistance will prevent regulatory compliance drift in the facilities which have been successfully certified but have failed to follow the discipline of quality management.