The pharmaceutical industry is highly sensitive with authorities requiring strict adherence to set rules. Some of these requirements are so complex that you require the assistance of GMP compliance consultants to master them. There are numerous quacks in the industry likely to put you into more trouble other than help you. How do you identify the right consultant to work with?
In what areas do you require assistance? Your operations are on-going with some regulations having already been met. You have even overcome some of the most complex rules. Define the areas that are problematic and require expert assistance. This gives you tangible expectations when discussing with your consultant. It is these issues that go into your 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.
Check on the experience of your consultant. A consultant will offer guidance on how things are done. To get the perfect picture and reliable guidance, engage a person who has at least manufactured drugs. Some may have worked in inspection for years and thus have no idea about the production environment. You need first hand experience to know what ails your quality system and cost effective solutions, etc.
It is misleading to place all your focus on quality and assume the process. Workers find shortcuts and will easily outmaneuver inspectors during production. This is why operation experience is crucial because it allows you to seal loopholes in production and thus avoid trouble with regulators. It adds incredible value to have a practical approach to production through a hands-on consultant.
No consultant is perfect. Though you have expectations and an idea of the kind of person you require, it is not always that you will find him. Each of them has strengths and weaknesses including having been fired from work or lacking desired practical experience. You need to find a person who meets the largest portion of your expectations and is ready to deliver. A strong character plays a crucial role in delivering on the task.
Retain control over the project. Despite the presence of a consultant and regardless of the much you are paying, you remain accountable for your operations. Note that you are not outsourcing your GMP to an outsider. When FDA visits your plant, they will show no mercy because the consultant screwed with your work. Remain in command and demand quality work. Have an idea of what to expect.
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.
In what areas do you require assistance? Your operations are on-going with some regulations having already been met. You have even overcome some of the most complex rules. Define the areas that are problematic and require expert assistance. This gives you tangible expectations when discussing with your consultant. It is these issues that go into your 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.
Check on the experience of your consultant. A consultant will offer guidance on how things are done. To get the perfect picture and reliable guidance, engage a person who has at least manufactured drugs. Some may have worked in inspection for years and thus have no idea about the production environment. You need first hand experience to know what ails your quality system and cost effective solutions, etc.
It is misleading to place all your focus on quality and assume the process. Workers find shortcuts and will easily outmaneuver inspectors during production. This is why operation experience is crucial because it allows you to seal loopholes in production and thus avoid trouble with regulators. It adds incredible value to have a practical approach to production through a hands-on consultant.
No consultant is perfect. Though you have expectations and an idea of the kind of person you require, it is not always that you will find him. Each of them has strengths and weaknesses including having been fired from work or lacking desired practical experience. You need to find a person who meets the largest portion of your expectations and is ready to deliver. A strong character plays a crucial role in delivering on the task.
Retain control over the project. Despite the presence of a consultant and regardless of the much you are paying, you remain accountable for your operations. Note that you are not outsourcing your GMP to an outsider. When FDA visits your plant, they will show no mercy because the consultant screwed with your work. Remain in command and demand quality work. Have an idea of what to expect.
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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