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?
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 kind of a consultant do you require? Consultants purport to know everything. The information given on their profiles and resumes is usually inflated. This may give you a false idea of what to expect. However, you are the one who knows what needs to be done. Be specific when asking questions and focus on both soft and hard skills. Look for a consultant who will deliver a customized 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.
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 kind of a consultant do you require? Consultants purport to know everything. The information given on their profiles and resumes is usually inflated. This may give you a false idea of what to expect. However, you are the one who knows what needs to be done. Be specific when asking questions and focus on both soft and hard skills. Look for a consultant who will deliver a customized 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.
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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