The theme for the conference was ‘USFDA- Steps for Sustained Compliance’
The Indian Pharmaceutical Association (IPA), Industrial Pharmacy Division, jointly with IPA MP State Branch and Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently organised the first technical conference in Indore. The theme for the conference was ‘USFDA- Steps for Sustained Compliance.’
Dr RS Rijhwani, Chairman of Industrial Division, IPA welcomed the guests and laid the foundation of the programme by stating that regulatory expectations on quality and vigilance are constantly rising. Kaushik Desai, General Secretary, IPA, briefed the delegates about activities of IPA in the platinum Jubilee year and forthcoming international students convention and IPA convention in April 2015. Dr MM Borkar, Director-Plant Operation, Pfizer highlighted the three elements of robust quality systems – quality management approach; process-based approach and continuous improvement and told that robust QS enables better performance.
Sanjay Gorana, Plant Head, Cipla called upon the delegates to be quality personnel all the time and to ensure compliance with regulators’ expectations. He said that that all decisions should be science based, risk based and unbiased.
Ajit Singh, Chairman, ACG Worldwide, emphasised that US FDA and US need India more than India needs them. This is because US President is keen to see that every prescription costs less than $4 to the patient and this cannot happen unless it imports formulations from India and China. Hence, again, India has the advantage over China because the Indian pharma industry’s entrepreneurs and workforce have more pharmacy personnel than China. He called upon the Indian pharma industry to protect its brand image as quality manufacturer by learning to share its information in a befitting manner and focusing on behavioral aspects during audit. He opined that behavioral scientists are needed more than technocrats and even urged US to understand Indian ethos represented by Indian pharma industry. SD Joag, Secretary General, IPA ably compered the programme.
Dr Ganadhish Kamat, Executive Vice President – Quality Assurance, Lupin described failure investigation as one of the ten deficiencies cited by US FDA while investigating on product failure, utility, quality system, market complaint and deviation. He talked about assignable and common causes of failure, key investigation skills and statistical quality control tools like Brain storming, Five Whys, process flow diagram, FTA, FMEA, cause and effect diagram, histograms, control chars etc and proper investigation report as the final outcome.
SM Mudda, Executive Director, Technical Operations, Micro Labs talked about quality as product realisation based on ICH Q10. He described GMP as first stepping stone which is more of need and quipped that there is no consensus about ‘G’ in GMP. He held six sigma systems based approach to GMP centering around quality systems and PQS as second stepping stone as this involves large management responsibility. He described a engraining quality culture as third stepping stone which is the sum total of mindset, capability and systems.
Dr Subhash Pande, Senior Vice President, Corporate QA, Zydus Cadila gave tips on hosting a regulatory inspection. He explained the role of audit coordinator, escort team comprising plant head, corporate QA-RA representative & Site QA Head, second line personnel to support escort team, runners and experts like people from R&D, ADL, IT etc to assist second line team to ensure proper and timely compliance to auditors’ requirements.
Santosh Savarkar, Associate Vice President Regulatory Affairs, Alembic, hinted at several indiscretions observed by US FDA in terms of alerts, warning letters, import restrictions etc and explained what constitutes delaying, denying, refusing to auditors GMP inspection. He stressed on the importance of ethical and behavioral aspects much as quality in establishing a fruitful culture.
Sanjay Gorana, Plant Head, Cipla made fine distinction among correction, corrective action, preventive action and adaptation while speaking on CAPA tracking, an important element of pharmaceutical quality systems. He referred to various internal and external quality data like batch rejection, deviation, complaint, recall, rejection, adverse drug event etc to arrive at non-conformities. Root cause analysis of nonconformity should be science and risk-based and should end up with concrete action like change in design, machine, method or material. This reflected on intellectual and technical capability of an organisation. Verification of CAPA needs to be done by QH review form.
Dr Premnath Shenoy, Director, Patient Safety & Regulatory Affairs, Astra Zeneca referring to 21CFR11, spoke on the subject of data integrity, believed to be vital in US FDA audit of Indian and other companies. He explained the validation requirements while using hybrid system (paper and electronic), computerised system and system interface as in case of LIMS.
Matilda George, General Manager Quality Control, Ranbaxy gave a fine account of GXP requirements in a QC laboratory that culminates into reproducible, reliable, auditable and acceptable data. She elaborated on gamut of documentation ranging from policy, system procedures, laboratory manual, specifications, operating procedures, validation protocols and reports, forms and formats etc. and hinted that they should meet with 4 ‘C’ requirements of clarity, comprehensiveness, conciseness and correctness. She highlighted on the growing importance of microbiology in pharma analysis.
The programme concluded with a question-answer session coordinated by Dr JB Dave, an active functionary from Gujarat who conveyed his opening remark that exports to developed countries has not only brought revenues but scientific, technological and regulatory advances into practice along with sound work ethos. The delegates posed many questions centered around data integrity, challenges in validation & QC operations and the same were aptly replied by the speakers. All in all, the conference provided a very learning and satisfying experience to one and all.
EP News Bureau – Mumbai