Management Responsibility for GMP and their Typical Oversight

The FDA has mandated CGMP or Current Good Manufacturing Practices which ensures the medicines to be safe and potent with the right materials.

The implementation of the effect of CGMP unacceptance on the business structure is not at all theoretical. Many examples has been set up in the pharma industry where proofs of ineffective integration of Current Good Manufacturing Practices systems resulted to bring loss of control which has affected the product by its quality materially, that which has also left scope to affect inventory and directly for patient supply. Setting up a Pharmaceutical Quality System (PQS) that viably executes the CGMPs is the methods for keeping up a condition of control—the central aim of these directions.

Management does not accept places of accountability with the purpose of ignoring CGMP acceptance. Nonetheless, management may not enter the best position completely prepared to accept responsibility for CGMPs for all intents and purposes. Management may assign all CGMP matters to the Quality Department and adopt a hands-off strategy and depend on this capacity to draw matters out into the open at their circumspection. Such lack of involvement prompts hearing just the terrible news when it is extremely late to contain and resolve the issue in the most financially savvy route with slightest hazard to public security.

GMP. Pharmaceutical Development. Technology Transfer. Commercial Manufacturing. Discontinuation. Investigational products. Management Responsibilities. Process Performance & Product Quality Monitoring System. Corrective Action / Preventive Action (CAPA) System. Change Management System. Management Review. PQS. elements. Knowledge Management. Enablers. Quality Risk Management. © ICH, November 2010.

Similarly, some Quality Departments may not be sufficiently prepared to connect the space between top management and day by day tasks with successful structures and procedures that empower management to practice its responsibility for CGMP oversight. Again and again the default position is to depend upon the result of administrative examinations. Be that as it may, as one may expect, a great result can give a misguided feeling that all is well and good, and a poor result can be seen as the comprehensive rundown of issues. As in any zone of the business where dangers must be overseen, there is no preferred approach over having a deliberate management system set up that gives noteworthy information to know inside where your day by day activity remains at any given minute.

So, maintaining CGMP is utmost important for a pharmaceutical industry for both the company and the patients to survive. But there are times when companies fail to abide by this, often because of the oversight of management. So, here we have discussed some of the most common mistakes that the management do resulting in leaving a bad impact in the market. Let’s check out what are those:

  • Management often do not care about inspecting the quality of the products and leave them over them quality team only. Neglecting those checks many a time can leave us with not-so-good product.
  • The management team ignores checking the quality system because they think that running the business is more important forgetting that the business is running upon the product quality only.
  • Sometimes the managerial department assumes that the loss was not so deep. And thus necessary measures can be taken afterwards with time leaving the company towards deviation.
  • The problems may seem to be very common to them, as a result management ignores them.
  • Being over-confident about the quality of the product has often resulted in a negative result.
  • Additionally, taking the business for granted is a very common oversight.

So, management needs to take care of these factors and become aware of each and every issue of the company. Along with doing the business, they also need to check the quality of product is being maintained. Otherwise the result can be devastating.

Here, in the later part of this blog, we have discussed about the responsibilities that the management must take upon to avoid such situation. Let’s take a look at them:

Checking the Structure of Quality Management System

Though QMS does not have a definite structure to follow on. But the management must make sure that the system is running in accordance with the objective set by the company. If everything is inline, nobody will be able to decrease the quality of a product. The company must follow a supportive system which will keep on collecting data and taking adequate measures.

Performance Metrics

Measuring the performance metrics is a core task of the management and it should be done on an regular interval. It makes sure that both the employees and the machines are working in accordance. Leading a good QMS along with positive performance will definitely leave the company with positive results.

Staying Connected

Being at the top of the company, the management is responsible for everything. That’s why they cannot keep them aloof. The managerial department has to keep a continuous connection with even the ground level staff. The employees will feel their importance with this attitude and will be motivated towards something even better.

Different Quality Officers

Recruiting different quality officers for different level of the company can really give precise results. When there are different heads for operating site, business site, or corporate sites, then the individuals will not experience much burden and they can easily work. With less pressure they can check all the issues very minutely and then communicate them to the higher authority.

Establishing Key Quality Metrics

Knowing the most effective metrics, which can measure all the issues well, is beneficial. The problems then can be judged and analysed easily resulting in taking fast preventive actions. When we are facing any issue in the industry, we cannot afford to delay even for a little bit of time because every second is important, again both for the patient and the business to survive.

So, oversight may come in an industry but the management should be very careful of such situations. Being ignorant can never be a solution; rather they have to take upon necessary actions as fast as they can and including the entire team within this process can give much effective results.

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