Many may question the actual difference between Current Good Manufacturing Process (CGMP) and Good Manufacturing Process (GMP). First, GMP is a set of guidelines created by the Food and Drug Administration (FDA), designed to guarantee that pharmaceutical products are safe, pure, and of excellent quality. These ...

GMP: GMP is the part of Quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such ...

GMP violations can be easily avoided by keeping the following key points in mind. 1. Follow all guidelines provided by regulatory agencies. 2. Ensure that all processes conform to GMP requirements. 3. Ensure products are safe and effective. 4. Keep records of procedures and activities to ensure compliance ...

1. Get the facility design right from the start 2. Validate processes 3. Write good procedures and follow them 4. Identify who does what 5. Keep good records 6. Train and develop staff 7. Practice good hygiene 8. Maintain facilities and equipment 9. Build quality into the whole product lifecycle 10. ...

To the uninitiated, the difference between GMP and GLP can be a tough nut to crack. But as the names suggest, it is a no-brainer to uncover that they both deal with laboratory testing and ensuring the safety and integrity of drugs and chemical products. These terms often confuse many people and it is ...

Many may question the actual difference between Current Good Manufacturing Practice (CGMP) and Good Manufacturing Process (GMP). First, GMP is a set of guidelines created by the Food and Drug Administration (FDA), designed to guarantee that pharmaceutical products are safe, pure, and of excellent quality. These ...

Root cause analysis is performed to determine the root cause of errors or problems during the process. Root causes of out-of-specifications, production time deviations, and market complaints must be determined. Various methods are used for root cause analysis in pharmaceuticals. 5 Why is a useful and ...

1. Manufacturing Facility Design and Maintenance: The manufacturing facility must be designed to prevent and control contamination, product mix-up, and errors in the manufacturing and handling process. 2. Quality of raw material used in manufacturing: Raw materials are the key ingredients of pharmaceuticals ...

GMP: Good Manufacturing Practice is that part of Quality Assurance which insure that products are consistently produced and controlled the quality, standards appropriate to their intended use and required by the marketing authorization or product specification. Good manufacturing practice (GMP) could ...

=>> Final testing of the product cannot ensure the Quality efficiency and safety. =>> Final testing may always not detect contamination, error, etc. =>> Conformance to the predetermined specification. =>> To minimize contamination eg:- microbial contamination. =>> To eliminate error. =>> To produce product ...