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Regulatory compliance and quality culture

Pradeep Y Sarode
Wednesday, February 14, 2018, 08:00 Hrs  [IST]

It is well known fact in India that FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its cGMP regulations.

Quality assurance (QA) is a department put in place to make sure they can meet this obligations. Theoretically it is assumed that quality is covered in compliance of GMPs. But, now a day’s US FDA realised that companies are focusing only on compliance and not sufficiently concentrating on quality.

Regulatory compliance and quality are not the same. Compliance is simply putting out sufficient effort to meet cGMP’s minimum requirements. Quality is systematic continuous improvement process that deliver intended performance. This requires alignment of management, resources, products, and measurement systems. Quality is not only compliance, but even more such as improved productivity, increased profitability and building brand etc.

Ten years ago the US FDA created “A Vision for 21st Century Manufacturing.” With a goal for developing an efficient, flexible pharma manufacturing sector producing high-quality drugs without extensive regulatory oversight. It resulted in improvement of facilities, modernizing control platforms/process technologies, and rolling out quality-by-design (QbD) programmes, but the facts is that is it is far behind expected real improvement and creation of sustainable quality culture.

Recently the US FDA sent out a strong message to us on the need to adhere to a quality culture. The matter of product quality vs compliance has recently been given a push toward the quality side through US FDA office at India. FDA expects company should have capable production processes based on design; well-trained personnel who take responsibility for the quality of their work.

According to Crosby, “Quality is the result of a carefully constructed culture; it has to be the fabric of the organization.” The ultimate creators of quality products are people, not technology or formal quality procedures. Quality begins and ends with the individual; people manage processes and make the systems work; processes don’t do work, people do. It is people who make poor systems work and good systems fail. Hence employees’ mindset in tune of quality is a prerequisite for development of quality culture.

Simply like overdose of drugs may result in side effect which itself become obstacle for recovery of disease, overemphasis on compliance of GMP may also become the obstacle to quality culture. For example, GMP requires quality professionals must not report to an operation authority reasons may be fear of losing their independence and to avoid conflict of interest. Overemphasis on such independent reporting may become obstacle to quality culture development. Let’s identify the purpose of the quality function within an organization. The quality department neither produces product to be shipped, nor does it work to directly sell that product to customers. It role is mainly advisor, supporter and facilitator to other operations. Due to direct reporting to top management, QA behaves as if they are only people who had concern and care for quality and all others does not have the same. They behaves like superman who frequently exercise authority for tasks that they do not have the capability to perform which rightly should be performed by other departments. Examples are investigations of failures, writing of SOPs, validation, auditing/training of the department of which they lack knowledge,  etc. It also get reflected in their behavioural actions such as egoistic, coercive, partial, rude and inflexible nature. “Every action has an equal and opposite reaction” is applicable here and operation guy also behaves in smart way. They frequently regard cGMP compliance as a necessary government enforced evil, a non-profitable cost centre, and a barrier to business. Organisations with teams having such opposite perspective are likely to have weak quality culture. Example Organisation which have the quality assurance head who openly do loose talk that “On-time-delivery, productivity, cycle time, cost is not my business I have authority to stop any operation that I feel not complying with quality”.

Neither ISO 9000 nor TQM have “statement that mandates who should report to whom.” whereas the quality in automobile, Semiconductor as well as aerospace industry that follows TQM is far better than pharmaceutical industry.

Hyper-focus on compliance is also often an obstacle to quality culture. Generally classic pareto principle is applicable to quality issues.  Approximately 80% of quality issues highlighted are ought to be low risk and can be easily closed out. But, some quality professional frequently highlight such incidences to show up their importance. This indirectly influences operational people’s attitudes, values, and beliefs. They neglect 20% issues of major risk which need to be formally investigated for root cause.  Some of the examples are:
1.    The in house specification of API mentions requirement of 40#. The supplied API has 2% retention over and above 40#. Quality unit is rejected the consignment. Due to situational macro factors purchase was not in position to provide immediate replacement. The Supply chain is opined that API should be sieved through 40#  and used. Quality unit was rigid and it leads to loss of productivity.
2.    To match seasonal high demand in winter, Anti cold product was under production. Overprinting is legible, clear, and easy to read. But the letters are slightly tilting. Being as per expert being continuous inkjet printer it was difficult to adjust. Immediate delivery is required to avoid loss of market share  production being stopped by QA.
3.    The water used of HPLC is being procured from vendor who is not qualified/verified and the incoming water is not tested against specification. Purified water from in-house water system gives water of USP specification with total carbon within limit of specification of HPLC water. But, quality unit was reluctant to test and allow to use the same.
4.    SOP mentions self inspection by audit team but self inspection of own as well as other departments is being done by individual.
5.    Holding the dispatch of the batches as some corrections after review of batch sheet is incomplete while allowing the same when review is pending from Own department.
6.    Preparing and executing the process validation protocol require Team approach. Neglecting the same and protocol preparation/execution done by quality assurance person only.
7.    SOP revision is not made in time frame and then using coercive techniques on other department to complete the same.
8.    Misusing the Audit authority and auditing the premises of vendors with disrespect and rude behaviour.
9.    Ignoring preparation of APR which is critical requirement of Quality Compliance and when top management asked exercising the authority over other department to provide the data within 2 to 3 days.
10.    Allowing dispatch of FG goods based on primary results, when micro testing is delayed as microbiologist was absent on that particular date But the same is not allowed even when the distribution requires product urgently.

In such culture neither QA nor the concerned owes responsibility for quality. They only use figure pointing techniques against each other for non compliance.

As rightly said by Dan Judge, LNS Research, a real and meaningful danger facing quality leaders is lip service to quality without a hard and fast commitment to quality at the executive levels.

Ex. WHO GMP certified company QA head doesn’t have confidence on the medicines manufactured by his own unit hence He was taking same medicine manufactured by other companies for his diabetes. Lack of confidence on his own quality systems means lack commitment to quality.

Quality culture is a culture throughout the organization that continually views quality as a primary goal. It is the pattern - the emotional scenery - of human habits, beliefs, commitments, awareness, and behaviour concerning quality. (Juran)

Quality culture is primarily consist of two elements: Formal QA procedure/system/processes to define, measure, assure and enhance quality; and Attitude, belief, values of individual as well as team which build commitment to strive for quality.

Quality culture of a company is the basis for the public’s trust and confidence in their products.  Size of the company doesn’t make a company strong, it’s the culture – the strong sense of beliefs and values that everyone, from the CEO to the receptionist, all share. QA itself must not only talk about the importance of GMP compliance, but demonstrate their commitment to it in their day-to-day job functions. It is becoming increasingly evident that the success of future quality efforts will depend to a large extent upon the ability to create cohesive teams, in which members enhance, rather than impede each other's quality improvement ideas and efforts.

(Author is General Manager, Laboratories Griffon Pvt Ltd, Mumbai)


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