INTRODUCTION TO THE DEFICIENCIES IN AUDIT PART 1

INTRODUCTION TO THE DEFICIENCIES IN AUDIT PART- 1 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: • WHAT IS DEFICIENCY IN AUDIT? • CLASSIFICATION OF DEFICIENCY • MENTION THE TOP PHARMACEUTICAL ACCORDING TO FDA REPORT DEFICIENCIES

WHAT IS DEFICIENCY IS AUDIT? • To, describe in one word it is the Critical GMP failure. • Critical GMP failures occurs when a procedure of manufacturing a product could give rise to a product which is harmful for the patient. A combination of the major deficiencies which indicates a serious of system failure may also be classified as critical deficiency.

CLASSIFICATION OF DEFICIENCY A NON CRITICAL DEFICIENCY • Defined as a type of deficiency where a product is produced which does not comply with it’s marketing authorization or creates a major deviation from the terms of manufacturing authorization. • It may also mean failure to carry out satisfactory procedures for release of batches. • It may also mean failure of the qualified personnel to fulfil his legal duties.

CONTINUED… DEFICIENCIES WHICH ARE CLASSIFIED AS OTHERS: • It is defined as the deficiencies which are not at all major but the combination of many of these deficiencies may cause major deficiency which should be reported and explained. • These deficiencies cannot be explained because of lack of information but nevertheless they indicate deviations from the GMP. • They are not necessarily of a minor nature and are basically unclassified.

CONTINUED…. CRITICAL DEFICIENCY: • Defined as the deficiency which leads to significant risk of producing either a product which is harmful for the human or veterinary patient or a product which could form a harmful residue in a food producing animal.

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • What is deficiency in audit? • What are the different classification of deficiencies? Among them which one is the most dangerous and why? • Can you make a common list of deficiencies that may occur in a firm according to FDA?

The TOP pharmaceutical deficiencies according to FDA report • 21 CFR/211. 22(D)- Procedures not in writing fully followed. • 21 CFR/211. 160(B)- No proper presentation of Scientifically sound laboratory controls • 21 CFR/211. 192 - Investigations of discrepancies, failures. • 21 CFR/211. 100(a)- Absence of written procedures. • 21 CFR/211. 67(b)- written procedures not established or followed. • 21 CFR/211. 113(b)- Procedures for sterile drug products. • 21 CFR/211. 165(a)- Testing and release for the distribution • 21 CFR/211. 67(A)- Cleaning/sanitizing/maintenance. • 21 CFR/211. 68(A)- calibration/inspection/checking not done

CONTINUED… • 21 CFR/211. 110(A)- Control procedures to validate and monitor performance. • 21 CFR/211. 198(A)- Complaint handling procedure. • 21 CFR/211. 25 (a)- Training operations, GMP’s written procedures. • 21 CFR/211. 100(b)- SOP’s not followed or documented. • 21 CFR/211. 188 - Prepared for each batch which include complete information. • 21 CFR/211. 25 - Training operations, GMP’s written procedures

• IN THE NEXT VIDEO WE ARE GOING TO LEARN ABOUT • THE TOP PHARMACEUTICAL ACCORDING TO FDA AUDIT DEFICIENCIES OCCURING • PLEASE WATCH THE NEXT VIDEO FOR PROPER UNDERSTANDING

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