India has advantage over China because Indian pharma industry has more pharmacy personnel than China. Indian Pharma Industry needs 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. These were the thoughts shared by Ajit Singh, chairman, ACG Worldwide while delivering his message as the chief guest at IPA-Pharmexcil Technical Conference 2014.
He further opined that Indian pharma industry requires behavioral scientists more than technocrats and even urged the US to understand Indian ethos represented by Indian Pharma Industry.
More such deliberations and lectures were made by key industry leaders during the first technical conference at Indore on the theme ‘US FDA- Steps for Sustained Compliance’ hosted by Indian Pharmaceutical Association (IPA), Industrial Pharmacy Division, jointly with IPA MP State Branch and Pharmaceuticals Export Promotion Council of India organized on 7th November, 2014.
Speaking on sidelines of the event, Dr RS Rijhwani, chairman, Industrial Division of IPA said that regulatory expectations on quality and vigilance are constantly rising. While Kaushik Desai, Hon General Secretary briefed the delegates about IPA's forthcoming international students convention and IPA convention in April 2015, Paresh Chawla briefed the delegates about export promotion initiatives undertaken by Pharmexcil.
Dr MM Borkar, director, plant operation, Pfizer Ltd highlighted the three elements of robust quality systems - quality management approach, process based approach and continuous improvement and told that robust quality system enables better performance.
Sanjay Gorana, plant head, Cipla Ltd called upon the delegates to be quality personnel all the time and to ensure compliance with regulators’ expectations. He said that all decisions should be science based, risk based and unbiased.
Chief Guest of the event Ajit Singh, chairman, ACG Worldwide further emphasized that US FDA and US needs India more than India needs them. This is because US President is keen to see that every prescription costs less than 4 US$ to the patient and this cannot happen unless it imports formulations from India and China.
Speakers of the technical sessions Dr Ganadhish Kamat, executive vice president, quality assurance, Lupin Ltd described failure in 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 why's, 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 described quality as product realization based on ICH Q10. He described GMP as the 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 an 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 valuable tips on hosting a regulatory inspection. He explained the role of audit coordinator, escort team comprising plant head, Corporate QA-RA representative and 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 Ltd, 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 and 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 Ltd 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 non-conformity 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 organization. Verification of CAPA needs to be done by QH review form.
Dr Premnath Shenoy, director, patient safety and regulatory affairs, AstraZeneca 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), computerized system and system interface as in case of LIMS.
Matilda George, general manager, quality control, Ranbaxy Ltd gave a fine account of 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 pharmaceutical analysis.
Programme concluded with a lively 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.