Presentation on theme: "Good Manufacture Practice audits experience"— Presentation transcript:
1Good Manufacture Practice audits experience GMP+Good Manufacture Practiceaudits experienceIng. Alexandr Kopečný
2GMP+ AUDITS EXPERIENCE BREAF INTRODUCTION OF AUDITOR:Ing. Alexandr Kopečný – auditor of Moody International since 2003Approved 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)
3GMP+ AUDITS EXPERIENCE 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 requirementsC - documents – certification and „accreditation“ (and also so-called checklists for auditors)
4GMP+ AUDITS EXPERIENCE 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.
5GMP+ AUDITS EXPERIENCE 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and rules of certification:Document A1 (important):Validity of certificate is 3 years,In case that certicate is withdrawn, company is for one year excluded from certication process,In case that certicate is suspended is company red highlighted on
6GMP+ AUDITS EXPERIENCE 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
7GMP+ AUDITS EXPERIENCE Certified producers (GMP+ B1) can use feed, which was assessed for risk assessment and is registered in PDV databaseB-appendix No. 2:Database Risk Assessment Feed MaterialsIncludes desription of handling with database (so-called „positive list“),B-appendix No. 3:Negative list – minimum requirementsRegarding to forbidden substances for use in feed (e.g. kitchen waste, urine,…)
8CCP identification – risk analysis GMP+ AUDITS EXPERIENCECCP identification – risk analysisStepHazardP/SKatAction/limit/record/deposition/responsible personVerificationCorreective actionGRANULSDYIF –grit, screws, bonesB2POAGrading of raw materials /-/-/-/ screen staffPreventive maintenance/ Doc 64/ F 21/ work room/ serviceman……..………CH – rezidues of pesticides, cleaning agentsA2Analysis of input materials/ Doc 54/ F 7/ lab./ laboratorian,Cleaning procedures keeping / Doc 41/ F 1/ control room/ drier´s staff……….B – micro-organism, pestsC2CCPTemperature 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………..
9GMP+ B1, B2 – audit findings GMP+ AUDITS EXPERIENCEGMP+ B1, B2 – audit findingsAren´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),
10GMP+ B1, B2 – audit findings GMP+ AUDITS EXPERIENCEGMP+ B1, B2 – audit findingsAccessiblity 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.
11GMP+ B1, B2 – audit findings GMP+ AUDITS EXPERIENCEGMP+ B1, B2 – audit findingsCompany 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,
12GMP+ AUDITS EXPERIENCE 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).
13GMP+ AUDITS EXPERIENCE HACCP plans for transporters are already implemented in v GMP+ B4.1 standardTherefore isn´t necessary to do HACCP analysis for own companyHowever is necessary seriously keep HACCP (cleaning records).
14GMP+ AUDITS EXPERIENCE GMP+ B4.1 – audit findingsCompany 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).
15GMP+ AUDITS EXPERIENCE GMP+ B4.1 – audit findingsDrivers 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.