There are strict regulatory laws in the pharmaceutical industry that could easily land you in trouble if not followed. The assistance of GMP compliance consultants helps you navigate through these laws to avoid penalties by FDA and other bodies. This industry has been infiltrated by quacks who put many manufacturers at risk. What should you do to ensure that you hire the right consultant?
Establish the areas you need assistance. Some areas of operation are straight forward while others are complex. Identify areas where assistance is required. With a formal scope of work, you have a firm idea of what to expect. It also gives the consulting firm a basis for discussion. It is this breakdown of the scope of work that will be used to draft the final contract.
What level of expertise do you need from the consultant? The profiles and adverts made by consultants give an image of a know-it-all character. In most cases, these profiles are inflated. Relying on them could be misleading. What you need is a clear picture of what must be done. Ask the prospective consultant the right questions to gauge their hard and soft skills. Most importantly, get a consultant who offers a personalized package.
Experience matters in consulting. The work of a consultant is to provide guidance on what needs to be done. This can only be achieved if the person understands the drug manufacturing industry. There are inspection specialists who do not have practical manufacturing knowledge and skills. Their solutions may be based on book knowledge. You need cost effective and practical solutions. Find a person who can offer that.
It is not only about quality. Some consultants have only been in the quality assurance division. They lack solid operation experience that adds value to your production. You require a person who understands loopholes that would push employees into shortcuts that eventually land you into trouble. You will have a solid partner if you can tap into his or her experience.
You will not find a perfect consultant. Your expectations should not be to find a person who has all your desired qualities. They do not exist. Some have been laid off for different reasons while others lack the experience you desire. Find a consultant with a combination that is close to what you expect. Consider the character of the person and readiness to deliver to your expectations. You may get a referral from your peers in the industry.
Remain in charge of the project. Do not allow the consultant to take control of your operations despite paying him huge sums. Accountability for the work remains in your hands despite the feeling that you outsourced GMP. When FDA officers visit your factory, you will be answerable. They will not excuse you because a consultant screwed. Since you have written expectation, ensure that they are met.
Be ready to listen. A consult will be integrated into your team. This is not an opportunity to exercise your authority. Give him space to focus on his work and be reasonable with oversight. As much as you will need regular updates, they should not be grilling sessions. Listen and take note of their views.
Establish the areas you need assistance. Some areas of operation are straight forward while others are complex. Identify areas where assistance is required. With a formal scope of work, you have a firm idea of what to expect. It also gives the consulting firm a basis for discussion. It is this breakdown of the scope of work that will be used to draft the final contract.
What level of expertise do you need from the consultant? The profiles and adverts made by consultants give an image of a know-it-all character. In most cases, these profiles are inflated. Relying on them could be misleading. What you need is a clear picture of what must be done. Ask the prospective consultant the right questions to gauge their hard and soft skills. Most importantly, get a consultant who offers a personalized package.
Experience matters in consulting. The work of a consultant is to provide guidance on what needs to be done. This can only be achieved if the person understands the drug manufacturing industry. There are inspection specialists who do not have practical manufacturing knowledge and skills. Their solutions may be based on book knowledge. You need cost effective and practical solutions. Find a person who can offer that.
It is not only about quality. Some consultants have only been in the quality assurance division. They lack solid operation experience that adds value to your production. You require a person who understands loopholes that would push employees into shortcuts that eventually land you into trouble. You will have a solid partner if you can tap into his or her experience.
You will not find a perfect consultant. Your expectations should not be to find a person who has all your desired qualities. They do not exist. Some have been laid off for different reasons while others lack the experience you desire. Find a consultant with a combination that is close to what you expect. Consider the character of the person and readiness to deliver to your expectations. You may get a referral from your peers in the industry.
Remain in charge of the project. Do not allow the consultant to take control of your operations despite paying him huge sums. Accountability for the work remains in your hands despite the feeling that you outsourced GMP. When FDA officers visit your factory, you will be answerable. They will not excuse you because a consultant screwed. Since you have written expectation, ensure that they are met.
Be ready to listen. A consult will be integrated into your team. This is not an opportunity to exercise your authority. Give him space to focus on his work and be reasonable with oversight. As much as you will need regular updates, they should not be grilling sessions. Listen and take note of their views.
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