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 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 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.
There is no perfect consultant. You have an idea of your desired consultant but it is not obvious that all your expectations will be met. Some will have a history of being fired from their work places. Others were laid off while some might not have the practical experience you want. Find a balance between the qualities you need and what available consultants can offer.
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 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 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.
There is no perfect consultant. You have an idea of your desired consultant but it is not obvious that all your expectations will be met. Some will have a history of being fired from their work places. Others were laid off while some might not have the practical experience you want. Find a balance between the qualities you need and what available consultants can offer.
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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