GMP COMPLIANCE

IN BIOLOGICS —
IMPROVEMENT NEEDED
FDA Inspectional Observations (Biologics), 2007-2017
1 Top 3 cited FDA Form 483 observations

n Records, 606.160(a1, b)
n BPDRs, 606.171
n Equipment, 606.60(a)
n Investigations, 606.100(c)
n SOPs / procedures, 606.100(b)

300
Frequency of 483 observations

483 observations 250

associated
with SOPs / 200
(biologics)

procedures,
150
investigations /
deviations and
100
records have been
the top 3 most 50
cited categories
since 2012 0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Source data: https://www.fda.gov/ICECI/Inspections/ucm250720.htm

Top 5 inspectional observations (biologics), 2017

2 From inspections ending between 10/1/2016 and 9/30/2017,
data from FDA’s electronic inspection tools

5. E
 quipment calibration &
standardization (8) 1. Establish,
maintain and
follow SOPs (49)
4. Concurrent
documentation (17)

483S
3. Required
records (20) (BIOLOGICS)

The most 483s were cited against

21 CFR 606.100(b); SOPs were not
always established, maintained,
followed or available
2. Investigations (20)

PAREXEL’s team of former Regulatory agency employees and Industry professionals offer
time-tested compliance solutions for companies of all sizes and in locations around the world.

Source data: https://www.fda.gov/ICECI/Inspections/ucm250720.htm

Procedures not maintained / followed and

3 investigations account for 25% of 483 observations

n 483s, Procedures 100.606(b)

n 483s, Investigations 100.606(c) The proportion of
483s associated
with SOPs /
30
procedures and
investigations has
% total 483 citations (biologics)

25
remained
relatively constant
20 (% 483s per
annum) since 2007
15

10

0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

PAREXEL develop practical, tailored plans that align quality

capabilities with business strategy

4 Number of Form 483 observations (biologics)

3.0
Frequency of citations / number

2.5
of Form 483s issued

2.0

1.5

1.0

0.5

0.0
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

The average number of observations per Form 483

issued has remained relatively consistent since 2008

Source data: https://www.fda.gov/ICECI/Inspections/ucm250720.htm

PAREXEL CONSULTING
In the past 5 years, PAREXEL Consulting
has assisted over 500 global-footprint
PAREXEL’s team of former Regulatory
clients with:
agency employees and Industry
professionals offer time-tested • Inspection readiness (mock inspections,
compliance solutions for companies training, coaching, on-site support)
of all sizes and in locations around • Risk Mitigation (preparation of 483
the world. and WL remediation strategy with
on-going support)
We develop practical, tailored plans
• Meetings and regulatory communiques
that align global quality capabilities
(organizing meetings, preparation
with business strategy, understanding of presentations)
that preemptive compliance and
effective crisis management are • Enterprise-wide Operational Excellence
critical to a successful product journey. (Lean processes; sterile manufacture;
IT systems; process validation)
• Quality Metrics (for early detection and
To discuss how PAREXEL Consulting can risk prevention)
assist with your regulatory, manufacturing • Supplier Quality Assurance (CMOs,
or GMP compliance challenges please entire supply chain)
contact regulatory.portal@PAREXEL.com.
• Data Integrity Assurance

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