PI 028-1 Aide Memoire on Packaging - PIC/S

3.2. The <strong>Aide</strong>-<strong>Memoire</strong> is the direct result of the 2005 <strong>PI</strong>C/S Seminar. The <strong>Aide</strong>-<strong>Memoire</strong> should enable the inspector to assess the GMP compliance of thepackaging process using the quality risk management tools.4. SCOPE4.1 The following <strong>Aide</strong>-<strong>Memoire</strong> describes different areas which could be evaluatedduring the GMP inspection of packaging and labelling process. However, the<strong>Aide</strong>-<strong>Memoire</strong> should be considered as a non-exhaustive list of areas to belooked at during an inspection.4.2 At the time of issue, this document reflected the current state of the art. It is notintended to be a barrier to technical innovation or the pursuit of excellence. Theadvice in this <strong>Aide</strong>-<strong>Memoire</strong> is not mandatory for industry. However, industryshould consider <strong>PI</strong>C/S recommendations and <strong>Aide</strong>-<strong>Memoire</strong>s as appropriate._____________<strong>PI</strong> <strong>028</strong>-1 3 of 8 13 January 2009

Area ofoperation/ItemsNotes1.3 Storage areas • adequate capacity, orderand organization, locationplan available;• the cleaning status,procedure and records;• physically separated areasfor “quarantine”, “approved”,“rejected/recalled” materialsor a system that providessimilar safety;• secured conditions(physically separated areas,controlled, authorisedaccess) for storage ofprimary and secondaryprinted materials (cartons,labels, leaflets);• storage of one batch perpallet – when the number ofrecipients allows -, withoutmixing batches on the samepallet ;• storage conditions adequateto each category of materials(qualification of theventilation, air conditioningunit, critical parametersmonitoring – temperature,humidity);• existence of an efficientsystem to prevent entranceof rodents, insects or otheranimals;• adequate control overdestruction of materials.1.4 Quality control • sampling plan andconditions, according to thematerial being sampled;• specific laboratoryequipment for the testing ofpackaging materials;• testing of packagingmaterials/packages inaccordance with themethodology approved in themarketing authorization(functionality tests accordingto the manufacturerspecification and testsCrucial questions• Show me theseasonal/annualtrends and results oftemperature andhumidity monitoring• Show me the locationplan and recordsconcerning theseactivities• Show me the samplingplan and records forprimary packagingmaterials (includinglabels)• Show me the approvedspecification andcurrent results frominternal testing• Show me thecertificates issued byQC for one or more ofthese materials /SupportingdocumentsGMP Guide3.1 – 3.4, 5.5,5.7, 5.28,5.29, 3.18 –3.23, 3.25GMP Guide –Annex 8:1, 5,3.40, 3.41,6.1, 6.6, 6.17,5.54, Annex1: 91<strong>PI</strong> <strong>028</strong>-1 5 of 8 13 January 2009

Area ofoperation/Items1.9 QualityassuranceNotes Crucial questions Supportingdocuments• performs operation reliablyand with no impact on thequality of the product;• training of maintenancepersonnel and contractors.• Quality policy, riskmanagement, riskassessment• self inspection system(frequency based on thecritical aspects of packagingmaterials/ processes, takinginto account the number andgravity of the quality defectsand taking the appropriatepreventive and correctivemeasures);• investigation of complaints toidentify the package/packaging related cause;• assessment of the changecontrol impact on thepackage/packaging of thefinished product, during thewhole shelf life of theproduct;• release procedure on printedand primary packagingmaterials;• release procedure of printedand primary packagingmaterialslevel of their knowledgeon the operations theyperform• Show me the recordsof training on lineclearance SOP• Show me the selfinspection plan andoutcome• How did youinvestigate thecomplaints related topackaging?9.1, 8.3, 8.6,Annex 15 –43, 446. REVISION HISTORYDateVersionnumberReasons for revision* * * * * * *<strong>PI</strong> <strong>028</strong>-1 8 of 8 13 January 2009