Amit Rajan, Managing Director, Prosfora Technologies, says that instilling a culture of compliance in a pharma set up is about nurturing, training and development of all the staffs concerned, on a continuous basis. It’s also about nurturing and inculcating an important cultural attribute, the need for being honest
The term Good Manufacturing Practice (GMP), implies the standards or good practices followed in core manufacturing of any item or product. However, it encompasses a broad spectrum of activity starting from testing, manufacturing, labelling and stability studies when used in the context of pharma products, interchangeably called as drugs or medicines. The pharma business is an extremely regulated one which the manufacturers have to comply in letter and spirit. These regulations have been codified in form of laws or guidances published from time to time by various pharma regulatory agencies across the globe. Compliance to the GMP code laid out, have, thus become a key rallying point between the pharma manufacturers and the regulators worldwide in recent days.
Significant violation to GMP was noticed at your manufacturing unit based at………
Numerous observations were made which were non compliance to the GMP requirements of 21 CFR part 210 &211 at your drug product site located at …….
Above are the typical content of the letters issued by drug regulators to the pharma units after inspection of their manufacturing units. If you ever a get a chance to read the finer details, you would find that the term “GMP” is used in the observations as varied as: How well the operators were dressed? How the materials were transferred from one place to another? How was the area cleaned? How was data written on the document? How was the material tested in the quality control unit? How good was the labelling operation? What was the temperature of the container in which the medicines were dispatched? How well the market complaints were recorded and investigated? These varied operations and the compliance levels that one has to follow in executing them, poses a natural question: “Is building a culture of GMP compliance about Nurture or Nature?
Instilling a culture of compliance in a pharma set up is about nurturing – training and development of all the staffs concerned, on a continuous basis. It’s also about nurturing and inculcating an important cultural attribute – the need for being honest. “Do what you document and document what you do” is like a preamble every one has to follow in the pharma sector. Every person involved in even the smallest unit operation has to follow this preamble for their works to qualify as “compliant”. The complexity of operations involved in a pharma set up, whether it is drug substance or a drug product unit, requires the culture of compliance to be built on a continuous basis. Readers may be aware that because of this need of culture of continuous learning due to fast changing compliance requirements, the terminology cGMP is in vogue as against GMP. The prefix “c” stands for “current” which reflects the continuity requirements of training and thus nurturing an able team to be ready to face fast changing requirements either of the new markets or of the new product technologies. On a lighter side, however, the argument amongst the pharma professionals on whether this “c” is to be documented as cGMP or CGMP has yet not settled!!
While the oral dosage form manufacturing is like technology, the sterile drugs (aseptic manufacturing) is both technology and art. Staff working in sterile manufacturing set-ups have to nurture a hygiene regimen which must be of highest standards. Aseptic manufacturing involves working in a microorganism-free environment which is paradoxical when understood from the fact that staff working in these areas themselves, are the biggest carriers of the microorganisms! Hygiene practices followed at these units have therefore been critically inspected by the regulators at pharma units based in India. Most of these units have failed to stand up to the regulators expectations and have thus been put under a warning letter or import alert. Failures, are partly due to the tropical nature of our territory and partly due to our own cultural attributes.
Compliance to GMP is an investment worth doing. We need to design our manufacturing units, install machines, develop technologies, write procedure and follow operations so that we do not put undue pressure on the compliance set up of the unit. Not following the Standard Operating Procedures (SOP), forcing an output more than expected, improper cleaning of equipment in a multi-product facility, non-concurrent documentation etc. are the hazards which put the maximum stress on compliance framework of any unit. All big pharma set ups in India have sometime or the other compromised on these critical compliance matters, thereby inviting criticism from various regulators. A combination of these non compliances leads to what we now know as the dreaded term “data integrity.” This term is a resultant of poor implementation of procedures, compromised honesty in operations (generally at the leadership level), trying to brush surprises under the carpet and destroying poorly documented data. Violations of the preamble discussed earlier in the article. Failure to meet this preamble in successive regulatory inspections have brought some of the big Indian pharma companies to the state of decimation.
Many of the pharma businesses in India are at the cusp of a cultural shift required for GMP compliance. They would all do good to ponder and implement on what Warren Buffet once said: “In looking for people to hire, you look for three qualities: integrity, intelligence, and energy. And, if they don’t have the first, the other two will kill you.”