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Good Manufacture Practice audits experience

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Presentation on theme: "Good Manufacture Practice audits experience"— Presentation transcript:

1 Good Manufacture Practice audits experience
GMP+ Good Manufacture Practice audits experience Ing. Alexandr Kopečný

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)

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)

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.

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and rules of certification: Document A1 (important): Validity of certificate is 3 years, In case that certicate is withdrawn, company is for one year excluded from certication process, In case that certicate is suspended is company red highlighted on

Remarks from GMP+: GMP+ is product standard, despite of so-called 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

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,…)

8 CCP identification – risk analysis
GMP+ AUDITS EXPERIENCE CCP identification – risk analysis Step Hazard P/S Kat Action/limit/record/deposition/ responsible person Verification Correective action G R A N U L S D Y I 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 Analysis of input materials/ Doc 54/ F 7/ lab./ laboratorian, Cleaning procedures keeping / Doc 41/ F 1/ control room/ drier´s staff ………. B – micro-organism, 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 ………..

9 GMP+ B1, B2 – audit findings
GMP+ AUDITS EXPERIENCE 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),

10 GMP+ B1, B2 – audit findings
GMP+ AUDITS EXPERIENCE 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.

11 GMP+ B1, B2 – audit findings
GMP+ AUDITS EXPERIENCE 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,

Findings categorization (e.g. for B4.1): Nonconformity cat. 3 (e.g. Records aren´t up-graded in comparison with LOG BOOKU more than 1 month in dispatching), Nonconformity cat. 2 (e.g. Records aren´t up-graded in comparison with LOG BOOKU more than 2 months in dispatching), Nonconformity cat. 1 (e.g. Transport of goods from category LR1).

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).

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).

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.

16 GMP+ AUDITS EXPERIENCE Questions & discussion:

17 GMP+ ZKUŠENOSTI Z AUDITŮ Thanks for Your attention.

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