DIFFERENCE BETWEEN GMP AND cGMP
AMIT KATOCH
JAKSTAR PHARMA , CEO . Author, Mentor, Brand Specialist, healthcare Expert ,Ex-Novartis ,Ex-Ciba-Geigy,3 decades experience in pharmaceutical marketing. Associated with Premium hospitals for their niche marketing .
As we continuously strive for excellence in pharmaceutical manufacturing, it’s essential to understand the key regulatory standards that guide our operations. One such distinction that often comes up is the difference between GMP (Good Manufacturing Practice) and cGMP (current Good Manufacturing Practice).
While both terms are fundamental to ensuring product quality and safety, there are critical differences:
GMP (Good Manufacturing Practice):
GMP refers to the basic set of guidelines established to ensure that products are consistently produced and controlled according to quality standards. These practices cover all aspects of production, from raw material sourcing to equipment maintenance and facility cleanliness, ensuring the product is safe for human use.
cGMP (current Good Manufacturing Practice):
The 'c' in cGMP stands for current, emphasizing that the manufacturing practices must not only comply with regulatory guidelines but must also stay up-to-date with the latest scientific and technological advancements. cGMP is a dynamic approach that demands manufacturers to continually innovate and improve processes to meet the evolving quality expectations and regulatory requirements.
In essence, GMP provides the foundation for quality assurance, while cGMP ensures that we are always in alignment with the latest developments and best practices in pharmaceutical manufacturing.
As manufacturing experts, adhering to cGMP is not just about compliance; it’s about maintaining a culture of continuous improvement, keeping pace with new technologies, and ensuring the highest level of safety and efficacy for our products. This mindset allows us to enhance product quality, reduce risks, and uphold our industry’s trust and reputation.
Let’s continue to align our efforts with cGMP standards and drive excellence across all our manufacturing operations.
Best regards,
Amit Katoch,
JAKSTAR PHARMA