Quality Management System in Pharmaceutical Company
We all know as a basic principle that any product has its identity in the market by its Quality. With all the controls deployed, it is still a challenging task to sustain the product quality throughout its life cycle as there are many external factors involved which could be beyond our control. In the Pharmaceutical Industry, the manufacturing procedures involve complicated steps with a very high potential to cause errors. Moreover, the Pharmaceutical Industry has to comply with stringent regulatory requirements with good documentation practices(GDP) to maintain all documents/records as per regulatory expectations. It is therefore quite imperative for a pharmaceutical product manufacturing company to establish an effective Quality Management System.
Nowadays in all manufacturing sectors, most of the company target minimum ISO 9001 2015 certification for third party recognition as a Quality-oriented firm. Almost all Pharmaceutical companies are implementing QMS at their level best. In Pharmaceutical Industry any product intended for commercial sale follows a Product lifecycle right from the development till expiry. It is mandatory for the manufacturing company to maintain all records of product for the entire product life cycle, as the end-users of the product are human beings/animals.
In a Pharmaceutical company, there are many activities which are carried out by various operations team to complete the entire product lifecycle right from material receipt to its expiry. All these activities have to be defined as SOP with formats as part of the QMS so that each activity is accomplished with the desired output consistently in compliance with applicable regulations -irrespective of the person who performs it. At the same time, It is equally essential that the QMS (Sop’s and Formats developed) is clear/ unambiguous and simple so that it can be effective. Each member of the various operations team has to diligently perform their duties and should be in compliance to the QMS at all times. Establishing QMS & maintaining the compliance state for all operations in the organization is always a challenging and vital task. Successful completion of the product lifecycle depends entirely on the successfully functioning of the QMS at all the phases of the product cycle.
In Pharmaceutical Industry, the scope of QMS may cover all activities and processes right from product development, facility planning, Equipment selection, procurement, construction, qualification, validation till the daily commercial production, and the distribution thereafter. There could be a potential risk involved at various stages. The risk associated with each activity /process must be identified and its impact must be evaluated with a mitigation plan. Similarly, Changes in a process or system, procedures, specifications, standards are inevitable as they may be triggered through various sources internal (Continual improvement) or external (eg. Amendment in regulatory requirements). Each such change should be evaluated and documented right from its initiation till closure with close monitoring and control. Moreover if the day to day operational deviations, errors, failures, etc. are not documented with adequate correction/ corrective actions and preventive actions based on a properly defined & approved procedure, the company may fail to maintain the necessary records for compliance of QMS/regulatory requirements.
Benefits of a QMS.
QMS can be useful only if it is implemented with the correct and clean objective and with a clear policy of NO falsification. This is very important because it is observed that most of the people fear to follow systems and invariably commit more mistakes to hide their original mistake. But if the basic foundation for the QMS is developed with the policy to always record the facts progressively then there will be no reason at any time to worry at all. It’s like “we don’t have to remember what we said if we have not lied”. Further, the QMS should be established by developing systems and procedures to suit the operations being carried out rather than simply duplicating or adopting it without careful evaluation. QMS should be customized solutions developed with an objective to comply with regulatory requirements and quality standards defined internally. In simple words “Define what you will do -Do what you have defined – Record/document what you have done” So by following QMS, day to day work becomes rather very easy as we have to just do what we have defined using standard formats. QMS is all about standardizing the procedures, implementing the procedures, and monitoring the effectiveness of the implemented procedure. Moreover, the records and documents generated as part of QMS is a useful data which can be used for any study /trending and to make necessary changes for the continual improvement of systems and processes. The QMS data also helps to analyze the failures and can help to apply or revise the corrective actions based on the trend analysis. By utilizing the QMS data effectively, all complicated procedures can be eventually simplified. With an effective QMS in place, the company can target to save manpower, time, cost, and improve product /process quality and avoid repetitive failures.
You will all agree that normally a situation is out of control when we do not have enough data or confidence to take the right decision at the right time. When we lack the necessary support information to decide what needs to be done, we may land up taking the wrong action. An effective QMS with the Data /records generated can play a vital role and come to our rescue here.
One of the most important benefits of QMS is that an Effective QMS can make available the necessary data instantaneously (easy retrievable) which can help in any investigation process. An effective QMS should assist in the self-introspection of the internal systems ( by using approved checklists). An effective QMS manages the day-day activities like change management, risk assessment, impact assessment, corrections & corrective actions, Handling of incidents/ deviations, vendor qualification, market complaints, process, and cleaning validation, equipment, and facility qualification, etc. which has an overall impact on the final product quality.
Currently, QMS is being handled through software applications which have made the handling of the data and tracing/ archival of the documents & records very easy and paperless.
Benefits of QMS during facility construction and Initial Qualification
During the construction of a pharmaceutical facility, there are many activities that should be tracked and controlled as per the regulatory expectations. This is always a challenge for the organization -especially for a greenfield or new set-up when there is no established QMS or QA team on board during the initial stages of the facility construction. QMS adopted/established at the early stages of a project helps to handle and record/document the changes or design deviations progressively in a project. Changes occurred or discrepancies observed with respect to the critical system during the construction stage should be monitored and controlled progressively, hence an established QMS will play an important role in this stage.
During the initial stage of facility construction when the organization may not have sufficient manpower strength to deploy and implement QMS, the services of a subject matter expert (SME) can be availed as a third party /External consultant who can be appointed to establish the necessary systems to monitor and control the activities during the Facility construction phase. An external consultant can provide a range of services in compliance with all regulatory guidelines right from developing systems and generating the documentation and records with ALCOA++ requirements. SMEs who are well versed with the current regulatory and statutory guideline requirements and with their rich experience and current updated knowledge of the current industry trends can add value to the task of establishing QMS for a Pharma Facility.
The systems established by the external Consultants during the initial stages of the project can be then handed over to the in-house team of the organization whenever they are on board to continue with the QMS after adopting/amending the same as warranted.
