Transcript GMP+

GMP+
Good Manufacture Practice
audits experience
Ing. Alexandr Kopečný
GMP+ AUDITS EXPERIENCE
BREAF INTRODUCTION OF AUDITOR:
• Ing. Alexandr Kopečný – auditor of Moody
International since 2003
• Approved auditor by PDV since 2005 (for
substandards B1-compound feed and feed
materials, B2, B3, B4.1, B5 at present)
• Focused on transporters (GMP+ B4.1)
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• Is necessary to be aware that e.g. not only standard
GMP+ B4.1 doesn´t apply to transporters, that not
only/and annex B14, but also documents from serie A,
annex B5, annex B6, etc.
• A - documents – basic requirements on cooperation and
orientation, terminology, use of logo, etc.
(expecially A1- is important)
• B – documents and annexes– standards and specified
requirements
• C - documents – certification and „accreditation“ (and
also so-called checklists for auditors)
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Requirements and rules of certification:
Document A1 (important):
• Certification company should certify all „business
units“ with common GMP+ activities,
• If there is another subject in company´s area
that provides the same activities under GMP+,
then must be certified all of them.
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Requirements and rules of certification:
Document A1 (important):
• Validity of certificate is 3 years,
• In case that certicate is withdrawn, company is
for one year excluded from certication process,
• In case that certicate is suspended is company
red highlighted on www.pdv.nl
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Remarks from GMP+:
• GMP+ is product standard, despite of socalled unannouced audit are canceled
since the 1st of January 2009 (e.g. in
GMP+ B1, GMP+ B4.1)
• Quality from the view of GMP+ = feed
safety
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Certified producers (GMP+ B1) can use feed,
which was assessed for risk assessment and is
registered in PDV database
B-appendix No. 2:
Database Risk Assessment Feed Materials
• Includes desription of handling with database
(so-called „positive list“),
B-appendix No. 3:
Negative list – minimum requirements
• Regarding to forbidden substances for use in
feed (e.g. kitchen waste, urine,…)
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CCP identification – risk analysis
Step
G
R
A
N
U
L
A
S
D
R
Y
I
N
G
Hazard
P/S
Kat
Action/limit/record/deposition/
responsible person
Verification
Correective
action
F –grit,
screws,
bones
B2
POA
Grading of raw materials /-/-/-/
screen staff
Preventive maintenance/ Doc 64/
F 21/ work room/ serviceman
……..
………
CH –
rezidues
of
pesticides,
cleaning
agents
A2
POA
Analysis of input materials/ Doc
54/ F 7/ lab./ laboratorian,
Cleaning procedures keeping /
Doc 41/ F 1/ control room/ drier´s
staff
……..
……….
B – microorganism,
pests
C2
CCP
Temperature and time of drying
controlled by computers/Doc 41/ F
40/ drier/ driers´s staff,
Initial materials analysis/ Doc 55/
F 8/ lab./ laborant,
DDD/ Doc 92/ F 19/ technician´s
office / technician
………
………..
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GMP+ B1, B2 – audit findings
Aren´t managed records regarding to last three
loadings and ways of cleaning after the last
loading in used trucks (eventually in tank
wagons) (relates to forms collating with these
records and signing by drivers),
Official position required by standard GMP+ B2
„loadings supervisor “ isn´t offical established into
position, but hasn´t set competences and
responsibilities,
(is necessary to concern sealing of tanks with
transported products in bulk and acquire records
and to confirm them by sufficient driver into
future),
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GMP+ B1, B2 – audit findings
• Accessiblity and topicality of prescriptions for
dosing of materials in production isn´t
sufficient,
• Is necessary to safe added warehouses
against birds,
• Some contracts doesn´t consist sufficient
specifications regarding to required quality.
• Accepted bills of delivery don´t consist
required specifications of purchased raw
materials.
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GMP+ B1, B2 – audit findings
• Company doesn´t conduct control of
allowed/prohibited substances, additives,
veterinary medicines etc. at present.
(with GMP+ database,…),
• Isn´t explicit traceability of ranks and
products at present – e.g. „A“ vitamine,
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• Findings categorization (e.g. for B4.1):
– Nonconformity cat. 3 (e.g. Records aren´t upgraded in comparison with LOG BOOKU more
than 1 month in dispatching),
– Nonconformity cat. 2 (e.g. Records aren´t upgraded in comparison with LOG BOOKU more
than 2 months in dispatching),
– Nonconformity cat. 1 (e.g. Transport of goods
from category LR1).
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• HACCP plans for transporters are already
implemented in v GMP+ B4.1 standard
• Therefore isn´t necessary to do HACCP
analysis for own company
• However is necessary seriously keep
HACCP (cleaning records).
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GMP+ B4.1 – audit findings
• Company doesn´t examine micro-biological
drosses in individual types of trucks – aren´t for
trucks with spiral conveyor and for silos till this
time.
• Recommendation – is appropriate to keep
records regarding to cleaning,… only once – in
transport document at present and in weighing
list. But more press on drivers to fulfill especially
the column “no residues…“ and into the
signature of loading receipt (especially of
medicated feeds).
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GMP+ B4.1 – audit findings
• Drivers don´t make visual control of cleanlinnes
of loading area after washing/cleaning in some
cases (see column „no residues after cleaning“)
and before the own loading.
• Work instructions for drivers replenish with
procedure and correction against water in-leak
into tank/silo, procedure in case of mixing and/or
contamination of goods/tank, procedure in case
of rainwater in-leak, etc.
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Questions & discussion:
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ZKUŠENOSTI Z AUDITŮ
Thanks for Your
attention.