PART3 PHARMACEUTICAL DEFICIENCIES CITED BY FDA PHARMACEUTICAL QUALITY

PART-3 PHARMACEUTICAL DEFICIENCIES CITED BY FDA PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA

LEARNING OUTCOME • After watching this Video lecture we are going to LEARN: • DISCUSS IN BRIEF ABOUT THE 8 MORE PHARMACEUTICAL DEFICIENCIES FOUND BY AUDITING OF A FIRM. • NAMES OF THE RULES NOT FOLLOWED ACCORDING TO CFR.

21 CFR 211. 67(A) CLEANING/SANITIZING/MAINTENANCE

21 CFR 211. 67(A) CLEANING/SANITIZING/MAINTENANCE • Equipment and utensils are not properly cleaned, maintained and sanitized at appropriate intervals. • This methods should be held during appropriate interval of time or according to batches to prevent malfunction, contamination that may alter the identity, strength, quality and purity of the drug product. • 63 pharmaceutical have this problem is their unit according to the audits done by USFDA (2014).

21 CFR 211. 68(A) CALIBRATION/INSPECTION/CHECKING NOT DONE

21 CFR 211. 68(A) CALIBRATION/INSPECTION/CHECKING NOT DONE • Routine calibration, inspection, checking is not done of the automatic, mechanical, electronic equipment. • Moreover, a written procedure is to be maintained according to which calibration, inspection and checking of different equipment is done which is not maintained and thus proper performance of the equipment is not assured. • 54 pharmaceutical company has this problem in their unit according to the audits done by USFDA (2014).

21 CFR 211. 166 (A) LACK OF WRITTEN STABILITY PROGRAMME

21 CFR 211. 166 (A) LACK OF WRITTEN STABILITY PROGRAMME • There is no written testing programme designed to access the stability characteristics of the drug product. • If there are no such written programme then problem arises with the validation of the process by which the stability is being maintained and tested. Then the reproducibility of the process is never the same with the previous batch being studied. • 51 pharmaceutical company have this problem according to the audits done by USFDA(2014).

21 CFR 211. 110(A) CONTROL PROCEDURES TO MONITOR AND VALIDATE PERFORMANCE

21 CFR 211. 110(A) CONTROL PROCEDURES TO MONITOR AND VALIDATE PERFORMANCE • Control procedures are not established which monitor the output, validate the performance of those manufacturing processes that may be responsible for causing the variability in the characteristics of in process material and drug product. • As a result of that manufacturing processes are not validated and so proper quality product is not achieved. • 51 pharmaceutical companies have problem in their unit according to the audits done by USFDA (2014).

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • What may be the other deficiencies that may occur in a pharmaceutical firm according to you. • Write those down in your copy and cope them up with the topics we are going to discuss after resuming the video.

21 CFR 211. 198(A) COMPLAINT HANDLING PROCEDURES

21 CFR 211. 198(A) COMPLAINT HANDLING PROCEDURES • There is a proper procedure for handling of complaints (written and oral complaints) that is not maintained related to drug products. • The handling of complaints may not be written of followed or may be deficiently written or followed. • 47 pharmaceutical companies have faced this problem in their unit according to the audits done by USFDA (2014).

21 CFR 211. 25 (A) TRAINING OPERATIONS, GMP’S WRITTEN PROCEDURES

21 CFR 211. 25 (A) TRAINING OPERATIONS, GMP’S WRITTEN PROCEDURES • Employees are not given training in the particular operations they perform or the operations they function. • Proper GMP’s written procedures and regulations are not followed for training operations of the employees. • 46 pharmaceutical companies have faced this problem in their units according to the audits by USFA (2014).

21 CFR 211. 100(B) SOP’S NOT FOLLOWED/DOCUMENTED

21 CFR 211. 100(B) SOP’S NOT FOLLOWED/DOCUMENTED • Written production and process control procedures are not followed in the execution of production and process control functions. Proper SOP is not followed which creates variability in the reproducibility of the product and thus proper quality is not maintained. • Documentation is not done during the performance of a process for production of a drug product. • 43 pharmaceutical companies have faced this problem in their units according to the audits done by USFDA (2014).

21 CFR 211. 188 PREPARED FOR EACH BATCH, INCLUDE COMPLETE INFORMATION

21 CFR 211. 188 PREPARED FOR EACH BATCH, INCLUDE COMPLETE INFORMATION • Batch products and control records are not prepared for each batch of drug product produced. • They do not include complete information relating to the production and control of each batch. • 43 pharmaceutical companies have faced this problem according to the audits of USFDA (2014).

CONCLUSION

CONCLUSION These are the common deficiencies that occurs in a industry that can be rectified. This deficiencies lead to degraded drug product quality which decrease the reputation of the company. Small other deficiencies together can cause a critical deficiency which can create a huge loss of the company. So there should always be proper rectification and of the deficiencies and maintenance of the rules as mentioned earlier.

Prepared by: Ms. Aditi Roy Mr. Ankit Saha Ms. Monika Mishra Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA