GDP requires a consistent approachThere is a more than one way to skin a cat, one might say so there is certainly more than one way to work with documents and for this reason alone GDP is critical. For example, you have a group of operators making up a batch of drugs on a rotating shift basis – they’re all completing the relevant batch records whilst adhering to the SOPs governing the make-up; the drugs are made [probably correctly], however upon QA review the specialist doesn’t fully understand some of the entries in the batch record.
There are blank spaces in some, date formats are different (EU vs US); felt pens, highlighters and biros are used to make the entries and mistakes are left scribbled out, ripped off or just left. How can the company stand over the integrity of the drugs when their own internal QA specialists can’t understand the batch records?
Answer: They can’t.
What next? Drugs in the bin, poor documentation equals poor assurance and that means lost revenue at best and lost customers or patient risk at worst!
How can we improve?Remedy: Good Documentation Practices. If everyone is utilising the same set of documentation rules, whether this be the people making drugs or the people checking HVAC (Heating, Ventilation and Air Conditioning) logbooks the message is clear. Follow the procedures or your work won’t be acceptable. If everyone handles mistakes with a single-strikethrough and initials and dates modifications, paginates in the form x of y; everything is consistent. Everyone can understand and QA reviews can be successful leading to getting product out the door.
Have clear training requirementsGood Manufacturing Practices (GMP) are fundamental to the success of drug manufacturing; GDP is fundamental to GMP. But how is this achieved? Training. Plain and simple. Training all personnel as to the criticality of GDP is essential. Show them how it is done, show them how is shouldn’t be done – make sure each person has a curricula detailing their training requirements and make sure training is fully documented and in cases of great importance such as GDP make sure there is an assessment so that the trainee can be verified to have understood the course.
Training doesn’t have to take long, it just has to be right. 30 to 60 minutes is sufficient to train people in the use of GDP – but make sure a robust document management plan is in existance first, use this as the driver to push out the importance of GDP, ensure that all documentation eventualities are addressed from labelling and cross referencing attachments to the usage of tip-ex (or rather not to ever use tip-ex – this is simply forbidden).
Work instructions are SOPs and will implement the requirements of the document management plans so that GDP simply can’t go un-noticed, after all if people are trained in procedures that they aren’t following properly this is going against the grain of the job brief as well as moving the business out of compliance in certain areas, which of course is completely unnacceptable, leaving the offenders open to disciplinary action.
GDP is here to stayClearly and simply, or rather to be blunt – GDP is here to stay and once proper procedures have been established, users trained and the wheels are in motion there is no turning back. QA will reject illegal entries and users will simply just apply GDP, well it is better than the sack. Once these have been implemented it will be quite difficult to NOT understand the point whilst at the same time people won’t be able to wonder why or how they were even there before GDP.
When is GDP applicable?When is GDP applicable? Officially, when completing documentation that supports the manufacture of drug products or offical materials, the storage, holding and distribution of goods are within the remit of GDP to name but a few. Professionally, it is good practice to apply GDP always – even when handling documents relating to test and development systems. If nothing else, GDP is as much part of Good Engineering Practice (GEP) as it is relevant to GMP, if in doubt apply GDP. At least you’ll sleep safely at night without worrying about noise in the night been your boss at the door.
GDP all the way!Enforcement. The Document Management Plan should detail how these documents should be verified to be correct. We’ve already mentioned QA reviewing batch records but they don’t necessarily get to see everything and to this end documents that are deemed to fall under the GDP umbrella should be audited to verify that people completing GDP entries are doing so correctly; this is standard practice and is a useful exercise, after all it is better identifying and resolving such issues sooner than later; the consequences of the FDA or EMEA findings faults during their own audits doesn’t bear thinking about!
So, GDP or not GDP? I think I’m safely on the GDP side of the fence, how about you? Plan to succeed with GDP and ensure your systems are set up properly. Otherwise you’ve simply failed by virtue of failing to plan!! Don’t delay, write your document management plan today!