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India Exploring PIC/S Membership

India’s Ministry of Commerce and Industry met with pharmaceutical companies in April to discuss joining the multinational Pharmaceutical Inspection Cooperation Scheme (PIC/S), The Economic Times of India reported. It notes that large pharma firms favor the move because it “would expand export markets,” while smaller companies expressed concern that they would have to meet stricter manufacturing […]

Bar Codes on Drugs Exported from India

India will require that individual cartons of drugs for export contain bar codes designating their source, The Economic Times of India reported in April. The requirement takes effect in July and is intended to ensure that drugs manufactured illegally in other countries cannot be labeled as coming from India. A proposal to require bar codes […]

Online GMP Training in India

U.S.-based Underwriters Laboratories will offer online GMP training to drug inspectors in India, Pharmabiz reported in early April. In addition to GMPs, training will cover GLPs and clinical research topics. The training “would definitely help our inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers […]

Data Integrity Laws in India

The Indian health ministry is planning to rewrite legislation covering the integrity of data submitted in regulatory applications to include penalties for those who violate the rules, PharmaBiz reported in April. While the current law states that data submitted must be authentic and certified, it does not contain a legal basis for punishing offenders. Problems […]

Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns

Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....

High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....

Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

Fear-based Relationships Antithetical to Progressing Quality Systems, While Measurement is Key, CDER’s Woodcock Stresses at ISPE Metrics Forum

The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing....

Comment Request on Drug Manufacturer Registration

FDA announced the opening of a comment period on the requirements for drug establishment registration and listing set out in section 510 of the FD&C Act. The comment period ends May 22.

EU Excipient GMPs Guideline

The European Commission (EC) released a final risk assessment guideline on GMPs for excipients in late March. The guideline points to ICH Q9 for basic principles and goes on to emphasize the need for focus on impurities risks as well as excipient traceability.
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