PRODUCT RELEASE PROCEDURES ARE YOU AT RISK? If ever you want to be jolted out of your early morning considered before that all important decision is made. slumber just pick up a recent edition of ‘The Gold “Do I or don’t I?” “Do I release, reject or what?” Sheet’. If this publication is new to you get a copy For those involved in this process the pressures are immediately; it provides a sobering reminder of what immense. Decisions are rarely ‘black and white’ or clear the FDA is finding in the pharma world and the cut; more usually a shade of grey. Time and commercial devastating consequences of ‘getting it wrong’. pressures are usually acute and the ever increasing complexity of your supply chain doesn’t help. Despite ‘Record Drug Recall Totals for 2009 these challenges the Product Release process must be Resulted from GMP Breakdowns’ efficient, robust and above all safe. (May 2010) Based on the worsening recall statistics some ‘Enforcement on Steroids: FDA Delivers companies are clearly falling short of the mark; way Twice the Drug Warning Letters’ short. So how good is your BMR? How safe is your Product Release process? Are you ‘at risk’? Consider (April 2010) your responses to the following: Once read, and suitably ‘jolted’, obvious questions quickly come to mind; “How did this mess happen?” 1. DO YOU RELEASE PRODUCT JUST “How can such catastrophic failures go unnoticed?” Any recall also brings into question the security and BASED ON THE BMR?... IF YOU integrity of the Batch Manufacturing Record (BMR) and DO, START WORRYING! Product Release procedures that allowed the batches in Product can only be released when you are absolutely question to escape. sure that the quality system supporting manufacture The BMR and the Product Release procedure is a critical is ‘in control’. Release can only be justified when you part of your Quality System. Vital information on the know, rather than assume, that fully trained operators who, what, when, how and where is reviewed and have used the right materials and components, followed procedures, operated clean, fully calibrated and maintained equipment within its validated state and followed the rules of GMP. To support batch release you simply must have access to Quality System ‘performance measures’ that tell the truth and nothing but the truth. Releasing product without accurate and reliable performance measures is a bit like a pilot landing ‘blind’ without dials and gauges; very dangerous. You may get away with it for so long but you will eventually crash. Before any ‘yes’ decision you must have the data to prove the Quality System is in control. This means having immediate access to information such as:
>> Audit and self-inspection reports for the entire
supply chain >> Change control history: have all changes important tasks gets lost when operators are told been implemented successfully? What is the everything is important. As operators struggle to get cumulative impact of minor changes? the job done there is also the danger that ‘signing’ becomes a ‘tick box’ exercise. The second consequence >> Repeat deviations: why have they of excessive signatures is even scarier, encouraging less happened again? accountability and responsibility. >> Equipment calibration and maintenance Years ago I was involved in helping a company status and trends: is equipment being investigate a costly packaging related recall. The cause operated within validated parameters? was simple enough, an incorrect expiry date. What I >> Contractors: are they being managed found fascinating was that over 80 people had seen and controlled? and signed to confirm that the expiry date was correct. Not one person picked up the error… I’m convinced >> Training and education ‘status’ of all involved, many had signed without even checking the label and including contractors and ‘temps’ accompanying documents, assuming that others before them had done the job. So there you have it, the more >> Performance of key utilities (trend data for signatures you have the more worried you should be! water, steam, gases, etc)
>> Environmental control 3. SIZE MATTERS. THE BIGGER YOUR
>> SOP status: are they all current, available and BMR THE MORE WORRIED YOU being followed? SHOULD BE >> Cleaning and sanitisation We were recently called into a company to help reduce their BMR ‘error rate’. Over 38% of BMRs 2. HOW MANY DOUBLE CHECK were returned to manufacturing because of mistakes and errors; the usual missing signatures, incorrect SIGNATURES DOES YOUR BMR calculations and missing data causing costly delays and CONTAIN?... IF YOU HAVE LOTS huge frustration. It became clear that the operators, a START WORRYING! disciplined and committed bunch, were actually being distracted by the size and complexity of the 270 page Some people have this bizarre, but understandable, BMR. notion that lots of double check signatures mean the process is safer and more secure. We now know that BMRs are usually a product of evolution. As the product the opposite is true. and process evolves through to Phase 3 Clinical Trials the BMR inevitably gets thicker and more complex Signatures are there for a purpose. They tell us before it finally becomes ‘registered’. No one sits down who did what and when. Signatures are also very and thinks about content, format and design and personal, reminding people they are responsible making the documents easy to use. We helped one of and accountable for their actions. Double or ‘check’ our clients reduce the size and complexity of their BMR, signatures are also there for a reason. These are achieving dramatic results… all in three days. reserved for those vital tasks that, if done incorrectly, can have a dramatic impact - weighing and adding >> A 270 page document was reduced to 20 materials and components, calculations, line pages in total clearances, reconciliations, approval of sterilisation >> Data entries were reduced by 27% (you will be charts and the like. amazed what you record and don’t use!) When we insist on too many check signatures two things happen. Firstly the importance of the genuinely >> Double signatures were reduced by 68% >> The 270 page BMR took, on average, 60 minutes to review and approve. The slimmer ABOUT THE AUTHOR version took only 15 minutes Martin Lush has over 30 years’ >> Most importantly the BMR ‘error’ rate reduced experience in the pharmaceutical dramatically. After six months of use less than and healthcare industry. He has 1% of BMRs required correction held senior management positions So, as far as most BMRs are concerned, less is more. in QA, manufacturing, QC and supply chain auditing and has conducted audits If you would like to dramatically improve the security and education programs for many hundreds of and robustness of your BMR and Product Release companies in over 25 countries. process please drop me a line at martinlush@nsf.org.
Our intensive two day course: How to Simplify and
Improve Your Batch Record Review Process will provide you with the tools and techniques to:
>> Decide what should stay in the BMR and what
can be removed
>> Reduce the number of unnecessary signatures
that do more harm than good
>> Improve document design to make your BMR
user friendly
>> Reduce the time required for review
and approval
>> Reduce the number of errors and reworks
>> Improve the security and robustness of your
Product Release process
We come to you and run this workshop on your
premises working alongside your subject experts.
For more information, contact pharmamail@nsf.org or visit www.nsfpharmabiotech.org
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Cite as: NSF International. June 2017. Batch Records and Product Release Procedures. NSF: York, UK.
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