The pharmaceutical industry is highly regulated with slight violations leading to heavy penalties. To ensure that your operations are in line with all laws and thus avoid landing in trouble with FDA or other bodies, it is advisable that you engage GMP compliance consultants. This industry is flooded with amateurs masquerading as specialists. What should you do to ensure that you land a reliable consultant?
Know the kind of assistance you require. There are areas whose requirements are obvious and easy to meet. Even the complex requirements, you are likely to have met some of them. Identify problematic areas where the assistance of an expert is needed. This helps you to formalize your discussion with tangible expectations from your consultant. In fact, you will use these issues as expected outcomes on your formal contract with the consultant.
What level and type of skills do you need? Consultants advertise their services as though they are experts in everything. They will inflate their resumes to show that they can handle everything under the sun. Since you know what is required at your work place, ask specific questions regarding delivery of these services. You need a combination of hard and soft skills to get the work done. Find a person who delivers such a 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.
Take heed to what the consultant says. Despite being the boss, consultants have first hand experience. In fact, you have hired them to advise you. Allow them to freely work and oversight them in a reasonable way. Be firm yet realistic when asking questions. Consider their views during briefing.
Know the kind of assistance you require. There are areas whose requirements are obvious and easy to meet. Even the complex requirements, you are likely to have met some of them. Identify problematic areas where the assistance of an expert is needed. This helps you to formalize your discussion with tangible expectations from your consultant. In fact, you will use these issues as expected outcomes on your formal contract with the consultant.
What level and type of skills do you need? Consultants advertise their services as though they are experts in everything. They will inflate their resumes to show that they can handle everything under the sun. Since you know what is required at your work place, ask specific questions regarding delivery of these services. You need a combination of hard and soft skills to get the work done. Find a person who delivers such a 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.
Take heed to what the consultant says. Despite being the boss, consultants have first hand experience. In fact, you have hired them to advise you. Allow them to freely work and oversight them in a reasonable way. Be firm yet realistic when asking questions. Consider their views during briefing.
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