In order to streamline the process of issuance of WHO-GMP Certificate of Pharmaceutical Products (CoPP) through a uniform procedure of review and joint inspections, the Drugs Controller General of India (DCGI) has asked all state drug controllers (SDCs) to direct manufacturers to submit applications as per the checklist based on drug consultative committee (DCC) recommendations.
In accordance with guidance laid down in the 47th DCC and to reduce the number of inspections for the same manufacturing sites for various reasons by officers of Central Drugs Standard Control Organisation (CDSCO) zonal, sub- zonal and state licensing authorities (SLAs), it has been decided to adopt procedures as specified for the inspectorate in India with primary focus towards quality compliance to product and manufacturing process, as per the DCGI directive.
Inspection shall be carried out as per the guidelines laid down at 47th DCC minutes, relevant inspection SOPS and self-appraisal checklist for compliance with respect to all WHO TRS guidelines and GMP and report shall be prepared as per guidance for GMP inspection report as specified with categorization of deficiencies.
The applicant shall submit the application along with supporting document and details as specified in the checklist and product summary sheet as per the guidance of 47th DCC. A detailed deliberation was made in the 47th DCC held on July 30 to 31, 2014 and a guidance of joint inspection was minuted under agenda.
As per the guidelines of DCC, SLAs should furnish following documents from the manufacture like application, site master file as per WHO TRS 961, copy of manufacturing license, list of approved products applied for issuance of CoPPs, list of SOPs, stability data both accelerated and real time, list of equipment and instruments, list of technical staff, their qualification, experience and approval status, manufacturing layout plan, process validation for 3 batches of each product, schematic diagram of water system specifying circulation loop and material of construction, if not provided with site master file, schematic diagram of HVAC system specifying terminal filter configuration if not provided with site master file.
Maharashtra Food and Drug Administration (FDA) had also two years ago urged CDSCO to consider industry’s plea towards easing out repeated joint inspections on same premises for loan licensing units in the country.
It was also suggested by the industry as to how CDSCO should simplify approval process for APIs and also provide short, medium and long term action plans.
With growing emphasis on boosting SMEs to help meet the regulatory requirements of not only India but also other major markets like US, Europe and Japan, there is an urgent need for the manufacturers who are revised schedule M compliant to upgrade to WHO GMP and those who are WHO GMP compliant to upgrade to US FDA or EDQM compliance.