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Analysis of GMP Inspections - 20 Jan 2017

In accordance with the Freedom of Information Act, the US Food and Drugs Agency (FDA) is able to make their inspection results available to the public. Conversely, inspection results of EU supervisory authorities is not easily available to the public .  However, the U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) is an exception as they recently published the 2015 GMP inspection deficiency data trend.

According to the MHRA they have "improved the way of gathering the inspection deficiency data". The new data trending can now allow stakeholders to identify:

In 2015, the MHRA inspected 224 UK manufacturers and conducted 79 inspections overseas.  In the top-ten list of "critical" and "major" deviations found in all inspected areas, findings regarding the quality system topped the list (see illustration 1). This is similar to recent FDA findings.

Most Cited Deficiency Groups (Top 10)

Ranking

Groups

Critical

Major

Others

1

Quality System

27

293

555

2

Complaints and Recall

10

25

94

3

Documentation

9

138

372

4

Quality Control

4

26

136

5

Computerised Systems

1

21

19

6

Production

0

161

357

7

Premises & Equipment

0

107

311

8

Validation

0

93

128

9

Personnel

0

41

95

10

Materials Management

0

19

134

Most of the respective findings in chapter 1 of the EU-GMP Guidelines (Pharmaceutical Quality System) refer to 1.4 describing the pre-requisites for an appropriate Pharmaceutical Quality System - and also to 1.8 describing the Good Manufacturing Practices needed. And MHRA focuses also on ensuring "that all updates to EU GMP were captured, reviewed and implemented":

Source: http://www.gmp-compliance.org/enews_05746_Interesting-Analysis-of-GMP-Inspections-published_15983,15660,15892,15656,Z-QAMPP_n.html

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