“Without well written and closely followed Standard Operating Procedures (“SOPs”) in place, or complete and proper resolution to an FDA Form 483, a company may be issued a Warning Letter which is a black flag in the drug manufacturing approval space." - Linda Evans O’Connor, VP & Chief of Staff
WESTBURY, N.Y. (PRWEB) November 12, 2019
As a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, Lachman Consultants’ team was perfectly aligned with instructing this group of future industry leaders in the overall definitions of, and considerations for, paying attention to the regulations that help to make a pharmaceutical manufacturing facility compliant and safe.
“Regulators from the Food & Drug Administration (“FDA”) will not only speak to the office team or management in a facility,” states Fran Zipp, President and CEO of Lachman Consultants, “they walk the facility floor, talk to your technicians, walk through your processes, and ask questions about drug manufacturing in your facility.” Linda Evans O’Connor, VP & Chief of Staff, took the audience through an overview of Part 210 and 211 of Title 21 of the Code of Federal Regulations, while breaking down many of the more complex elements.
O’Connor identified for the young professionals just how detailed an FDA audit may be, citing one example where a company might receive an FDA Form 483 simply for lab staff not following a proper and complete gowning process. The FDA Form 483, as explained to the audience, can be thought of as a list of observations/issues raised during an FDA audit that a company/facility must address and prove to the FDA that the observations/issues are resolved, that new procedures have been put in place, and those procedures are repeatable with a very high quality; all within 15 days. This is one of the critical scenarios that warrant a biologic, biosimilar, or other drug manufacturer to reach out to a consulting firm such as Lachman Consultants to help remediate and address the FDA’s concerns quickly. Lachman Consultants has over 40 years of experience helping companies answer complex FDA Form 483s and Warning Letters.
“Without well written and closely followed Standard Operating Procedures (“SOPs”) in place, or complete and proper resolution to an FDA Form 483, a company may be issued a Warning Letter which is a black flag in the drug manufacturing approval space,” notes O’Connor, “because when you think about the end of the road, we are talking about drugs that are being used by patients who need to be confident enough to quite literally stake their lives on them. With the importance and gravity the FDA audit process holds, the understanding of cGMPs is imperative for these young chemists and engineers to grasp both for the facilities they work in, and the patients that their companies ultimately serve.”
To stress why this specific message is so important, two other senior SME’s from Lachman Consultants presented to give more context. Both Keith Webber, Ph.D., VP of Biotechnology, and Paul Mason, Ph.D., Dir. of the Science & Technology Practice for Lachman Consultants presented further detailed information regarding the basics of cGMPs, elaborating on the ten basic principles & considerations of Good Manufacturing Practices, which include:
1. Personnel are capable/qualified to perform assigned duties.
2. Ingredients used in manufacturing have their purported or expected qualities.
3. Process validation ensures procedures used will consistently result in product with the
4. The production environment is suitable for intended purpose.
5. Finished product has its purported characteristics with end-product testing, effective
QC checks, or a combination of both.
6. Finished product retains its characteristics until its labeled expiration date.
7. Processes are always conducted under control, and as specified.
8. Prevention of product contamination, cross-contamination, and mix-ups.
9. Adequate records and procedures for thorough investigation of product failures.
10. Separation of functions/decisions of production and quality control.
Whether identifying proper expiration dates for finished drug products, or refining warehousing and distribution procedures with a first-in-first-out (“FIFO”) SOP, employees at all levels of the manufacturing process are responsible for meeting the quality standards of cGMPs. The team from Lachman Consultants brought knowledge and clarity to the young professionals in this sponsored ISPE training event, as well as bring the highest quality cGMP consulting to companies around the world to keep them compliant with the FDA, and more importantly to keep patients healthy and safe.
ABOUT LACHMAN CONSULTANTS
Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device, and Related Life Science Industries. Lachman Consultants delivers solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, and Training, which consistently exceed client requirements and expectations.
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Ilena Della Ventura