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Cracking the cGMP code

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Even if top management walks the talk, are these concepts filtering down to all employees, especially those at manufacturing plants, on the filling lines or at the packing stations?

For the fourth year running, Express Pharma brings to readers the Good Manufacturing Practices (GMP) special issue. Our first GMP special dated May 16-31, 2016 looked at the  skewed perceptions of GMPs, comparing it to the fable of the five blind men and the elephant. ( Our second GMP issue dated May 16-31, 2017 ( focussed on the upskilling initiatives of pharma companies in India. Our third edition took a deep dive into how GMPs can and should be implemented as early as possible in the formulation research and development life cycle, starting with the quality of key ingredients and APIs.

( From the nitty gritties of regulations governing excipients, this year’s edition focusses on building a culture of compliance. The latest infrastructure, the most detailed standard operating procedures cannot prevent a careless staff member from ‘forgetting’ to wear safety goggles and head gear during an inspection in clear violation of the written SOP.  Missing entries in logbooks, crossed out entries etc raise suspicions too. The reasons for such behaviour patterns could range from ignorance, forgetfulness, laziness, negligence, sheer cursedness to a deliberate attempt to sabotage a company’s reputation.

The current edition deals with the various kinds of non-compliance with current Good Manufacturing Practices (cGMP) and has perspectives of external GMP consultants hired by pharma companies to prepare them for GMP audits. Taken on as the ‘third eye’, these consultants were often approached as a last resort after internal efforts failed to rectify the faults or were not as succeeded as required. Fire fighting and damage control measures are painful and often do not sustain beyond a certain period of time. Employees seen as the ‘cause’ of the non-compliance may be terminated, but systemic issues may persist. The training prescribed by regulators is completed but the employees may leave.

But, companies have today realised that consultants bring an impartial view. Experts find that pharma companies are today hiring them to spot the weaknesses in their systems and processes, and to fill the skilling and training gaps. In other words, third party consultants are today being hired in a more proactive manner, often before a company goes in for an audit, to identify the weak links and suggest remedial action.

But beyond the process, it is about being alert to out-of-the-box causes for non-compliance, errors, out-of-specification results. External auditors play a big role in analysing the ‘What-ifs’, raising the alarm early and training their clients’ staff to think beyond the obvious. Thus, compliance is slowly moving from being a regulatory must have to a strategic endeavour.
Regulations too are evolving and regulators are re-defining GMP to include the way plant operators are attired, documentation protocols, transport of materials within the manufacturing plant, to how were market complaints recorded and investigated. Thus the ‘c’ in cGMP becomes crucial. Systems, processes and personnel have to be constantly updated to be as current as possible.

But change cannot happen overnight. Even if top management walks the talk, are these concepts filtering down to all employees, especially those at manufacturing plants, on the filling lines or at the packing stations? Most plants hire local labour, for manual tasks, like labelling of cartons. Training is considered a waste of time as most often these are short term contracts, resulting in expensive goof ups. For example, one excipient manufacturer recounts how a switch of labels between two batches, resulted in different batch numbers on the labels of the outer packing and internal cartons. Both consignments were rejected by the client as it would be seen as a GMP non-compliance because the batch numbers didn’t match. This was a goof up at multiple levels: the packer, the supervisor as well as the QA/QC teams.

Unless each person realises the importance of her own task and how it contributes to the bigger picture, there will be no incentive to change. Because change does not happen overnight. External consultants, however inspiring  or qualified they may be, cannot be held responsible to change the DNA of a company. The change has to be spearheaded by internal GMP champions, with the full support of the senior management. The shadow of GMP violations for some manufacturing facilities seems longer than usual and raises serious questions not just for the individual companies but also the industry as a whole. Can we learn from these miss-steps and resolve to forge a new path rom here on? We like to hear your experience with cGMP compliance. Whether it’s a work-in-progress or already a success story.

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