Gp5405 Gdp-who Checklist

Checklist for Audit according to GDP for pharmaceutical pharmaceutical products (WHO)

Guidance to auditor(s) This document is intended to provide structured assistance to conduct an audit against WHO “Good distribution practices” (GDP) for pharmaceutical products . t contains !e" #uestions related to the main standard chapters$ t shall not to be part of the audit report$ The chec!list is to be used %ith a noteboo! to log an" detailed entries that "ou can collect during the audit$ The ans%ers & 'es o or *+ for “not applicable” be consistent %ith respect to #uestions that do not appl"$ +n +n asteris! and noteboo! page number should be entered on the chec!list to identif" %here relevant comments observations or #uestions are recorded in the auditor,s noteboo!$

 Yes  Yes !o or !"A

Item  O#GA!I$A%IO! A!D &A!AG'&'!% s the distributor authori-ed to perform its activities. s there a #ualit" management s"stem implemented. s the compan" certified /O or others.  +re the responsibilities responsibilities authorit" authorit" and relationships relationships in the organi-ation organi-ation defined. defined. s the current organi-ation adapted. s there for each distribution point a person %ith the responsibilities and authorities to assure that the #ualit" s"stem is implemented and maintained.  +re the resources resources (technical (technical and managerial) managerial) adapted to set up and to maintain #ualit" management s"stem. Does the scope of responsibilities of each individual generate an" ris! to product #ualit".  +re there arrange arrangements ments in place place to assure that that there are are no conflicts conflicts of interest.  +re the responsibilities responsibilities of each each person person described in a 0ob description. description.  +re the responsibilities responsibilities of each each person person ac!no%ledged ac!no%ledged and understoo understood. d.  +re some activities activities outsourced outsourced or delegated. delegated. f "es is the contract or agreement documented and mentions the activities concerned.  +re there an" an" periodic periodic audits of those those activities.  +re there procedur procedures es in place dealing dealing %ith safet" safet" propert" propert" of the personnel personnel environmental environmental protection and product integrit".  P'#O!!' s there a %ritten training program. Do all people involved in distribution activities receive training about the re#uirements of  GDP. Do the !e" people involved in distribution of pharmaceutical products have the abilit" and e1perience corresponding to their responsibilities.  +re there an an ade#uate ade#uate number number of competent competent personnel personnel involved involved in all stages stages of the distribution process.  +re the national national regulations regulations regarding regarding the the #ualification #ualification and e1perience e1perience of personnel personnel follo%ed. s there a 0ob description for the personnel including temporar" emplo"ees.  Did emplo"ees receive an initial training and continued training for their assignments tas!s.

Document2

GP3453

ssue n62

7

Page n62

7 of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item s the effectiveness of the training assessed. s there a specific training for the personnel dealing %ith ha-ardous pharmaceutical products (narcotics radioactive products9).  +re there records relating to training available for each emplo"ee including temporar" emplo"ee.  +re emplo"ees training and #ualification records !ept. s there a procedure for training addressing both permanent and temporar" emplo"ees.  +re there procedures in place ensuring a good h"giene of personnel.  +re personnel involved in ha-ardous products %earing a suitable garment. s there a first:aid procedure and e#uipment available for dealing %ith emergencies for personnel.  +re there procedures in place to minimi-e the access to the pharmaceutical products b" unauthorised person. s there a disciplinar" procedure to prevent or to address situations %here persons involved in the distribution of pharmaceutical products are suspected. *+AI%Y &A!AG'&'!% s there a #ualit" management s"stem in place. s there a documented #ualit" polic" describing the intentions of the distributor in terms of #ualit".  Does the #ualit" management include infrastructure procedures processes and resources.  +re the ;+ organi-ation,s authorities and responsibilities clearl" defined in %riting. Does the #ualit" s"stem cover the main principles of #ualit" assurance described in WHO guidelines.  +re the responsibilities of #ualit" and safet" shared %ith all parties involved in the distribution of pharmaceutical products. n case of e:commerce are there procedures and ade#uate s"stems to assure the traceabilit". s there a %ritten procedure and records to assure the traceabilit" of the product distributed throughout the suppl" chain.  +re there authori-ed procedures for all administrative and technical operations performed.  P#'&I' WA#'HO+I!G A!D %O#AG'  s there an ade#uate securit" to prevent unauthori-ed persons from entering storage areas. s the storage capacit" large enough to allo% an orderl" storage of the various categories products (bul! finished products product in #uarantine released re0ected returned recall products). s the storage area designed and adapted to ensure good storage conditions.  +re facilities (including pallets) maintained in a clean dr" and orderl" manner and in a good state of repair.  +re the special conditions of storage provided chec!ed monitored and recorded.  +re the products stored off the floor and is there a suitabl" space to permit cleaning and inspection.

Document2

GP3453

ssue n62

7

Page n62

< of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item s there a %ritten sanitation program indicating the fre#uenc" of cleaning and the method to clean the premises and storage areas. s there an ade#uate and %ritten pest control program.  +re the pest control agents used safe for the materials and the pharmaceutical products.  +re there appropriate procedures for the clean up of an" spillage to ensure an" ris! of contamination.  +re the receiving and dispatching ba"s able to protect products from the %eather. s the reception area e#uipped to allo% the cleaning of the containers before storage. s the #uarantine area clearl" designed and its access restricted to authori-ed personnel. f a computeri-ed s"stem is used to replace ph"sical #uarantine is the s"stem validated to demonstrate securit" of the access. Does the sampling in the storage area performed to prevent an" cross: contamination. s there an ade#uate procedure for cleaning of the sampling areas. s there a ph"sical and identified segregation (or e#uivalent) for the storage of re0ected e1pired recalled and returned products.  +re ha-ardous products narcotics radioactive products or products presenting a special ris! stored in a dedicated area. s there additional safet" and securit" measure for ha-ardous products narcotics9.  +re the pharmaceutical products handled and stored to prevent cross:contamination.  +re the products handled and distributed to prevent contamination mi1:up and cross: contamination. s the principle of ==O and =>=O applied.  +re the re0ected products identified and stored in #uarantine areas until a final decision is ta!en.  +re the international conventions national la% and regulations applied for the storage of narcotics.  +re bro!en and damaged products eliminated from the usable and separate stoc!. s the lighting ade#uate to allo% operations in safet" conditions.  +re the storage conditions in compliance %ith the information on the label.  +re the records of the temperature monitoring data available. s the e#uipment used for the temperature monitoring chec!ed at suitable predetermined intervals.  +re the monitoring records !ept for at least the shelf life of the product ? 7 "ear or as nationall" re#uired. s the temperature uniform in the storage facilities. s the e#uipment used for temperature monitoring calibrated at defined intervals.  +re there records for each deliver" including the description of the products #ualit" #uantit" supplier and supplier,s batch number date of the receipt assigned batch number and e1pir" date.  +re these records !ept according to national regulations or at least the shelf life of the product ? 7 "ear.  +re there %ritten instructions describing the s"stem of storage and the route of the products.  +re permanent %ritten or electronic information available indicating the conditions of storage precautions to be observed and retest dates.  +re pharmacopoeial re#uirements and current national regulations concerning labels respected.

Document2

GP3453

ssue n62

7

Page n62

@ of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item s there a procedure in place for 2 : Temperature mapping. : /ecurit" at the %arehouse. : Destruction of unsalable stoc!s. : Aetention of records. s a periodic stoc! reconciliation performed (actual v*s recorded). n case of significant discrepancies is there an investigation to chec! eventual mi1:up.  +re the containers ph"sicall" verified.  +re the incoming deliveries chec!ed against the relevant purchase order. ,'HIC' A!D '*+IP&'!%  +re the vehicles and e#uipment suitable for their use.  +re the vehicles and e#uipment suitable protection to prevent e1posure of the products to conditions that could affect their stabilit" and pac!aging integrit". Do the design of the e#uipment and the vehicle allo% an effective cleaning and maintenance.  +re there dedicated vehicles or e#uipment to handle pharmaceutical products. f the vehicle or e#uipment is not dedicated is there a procedure to prevent negative impact on the pharmaceutical products. s defective e#uipment or vehicles removed and labeled.  +re there procedures for operations and maintenance of e#uipment and vehicles. s there a procedure for the cleaning and safet".  +re the vehicles containers and e#uipment !ept clean dr" and free from accumulated %aste. s there a %ritten cleaning procedure (methods fre#uenc").  +re vehicles containers and e#uipment !ept free from pests (birds rodents vermin9). s there a %ritten program for pest control. s a stud" performed to chec! that cleaning and fumigation have no impact on the product #ualit". s special attention given to the design cleaning and maintenance of e#uipment used for the handling of products %ithout protective shipping carton.  +re the special storage conditions during the transit provided chec!ed monitored and recorded.  +re the monitoring records !ept for at least the shelf life of the product ? 7 "ear or as nationall" re#uired.  +re the monitoring data revie%ed at the receipt of the product to ensure that re#uired storage conditions have been maintained during the transport. s the e#uipment used for monitoring calibrated. s there enough e#uipment to perform all the re#uired operations %ithin the re#uired time frames. s there segregation for the re0ected recalled and returned products during the transit.  +re the products safel" pac!aged correctl" labeled and accompanied b" appropriate supporting documentation.

Document2

GP3453

ssue n62

7

Page n62

4 of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item s there a s"stem in place to prevent unauthori-ed persons from entering or tampering %ith vehicles and e#uipment and to prevent the theft. CO!%AI!'# A!D CO!%AI!'# A-'I!G  +re the pharmaceutical products stored and distributed in ade#uate containers (no interaction no contamination9).  +re the labels applied on the containers clear unambiguous indelible and %ell fi1ed on the containers. Does the information in the label compl" %ith applicable national legislation.  +re the labels %ritten in a language understood b" all people involved in the distribution chain. s all information relating to the handling storage precautions indicated on the label.  +re special transport and storage conditions including safet" s"mbols stated in the label.  +re onl" international or national codes used on the label of containers %hen in use.  +re all the precautions ta!en to prevent contact %ith dr" ice %hen in use. s there a procedure in place for the handling of damaged or bro!en containers and especiall" for ha-ardous and to1ic products. DIPA%CH  +re the products sold or distributed onl" to persons entitled to ac#uire these products according to national regional or international legislation. s there a document to prove the authorities of persons or entities entitled to ac#uire these products. s the deliver" order validated before the beginning of the dispatch or the transport.  +re there %ritten procedures for the dispatch ta!ing into account the nature of the product and the specific precautions to be observed. Does the record for the dispatch include 2 : The date of the dispatch. : The name and the address and the status of the addressee (hospital clinic9). : The name dosage form and strength. : The #uantit" of the products2 number of containers and number of products per container. : +ssigned batch number and e1pir" date. : Bondition of transport and storage. : The identification of deliver" order. s there enough information about traceabilit" in the record to facilitate the recall of the product if necessar". Does the selection of vehicles ta!e into account the local conditions (climate seasonal variations9). s there a schedule and a route planning %hich are realistic and s"stematic. s the principle first:out*last:in applicable for the load. s some deliver" of pharmaceutical products performed after or close to the e1pir" date. %#A!PO#%A%IO! A!D P#OD+C% I! %#A!I%

Document2

GP3453

ssue n62

7

Page n62

3 of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item Do the entities responsible for the transportation receive the relevant conditions for storage and transportation.  +re there procedures in place to prevent damage during the transportation and the storage2 lost mi1:up or cross:contamination spillage brea!age theft9.  +re appropriate temperature and relative humidit" conditions maintained during the storage and the transportation if necessar".  +re there %ritten procedure to fi1 acceptable limits and acceptable period of e1ceeded time for storage conditions.  +re the special conditions re#uired for the transportation provided monitored and recorded. s there a %ritten procedure in place describing investigations and actions for deviation of  storage conditions.  +re dangerous to1ics and narcotic products stored and transported in safe conditions.  +re the national or international re#uirements follo%ed. s there a %ritten procedure in place to prevent contaminations %hen spillage occurs. s there a ph"sical or e#uivalent segregation for the storage and the distribution during the transit of re0ected e1pired recalled and returned products.  +re these products correctl" identified securel" pac!aged clearl" labeled and accompanied b" an appropriate document.  +re the interiors of the vehicles and containers maintained clean during the transit.  +re the pac!aging materials and transportation containers suitable to prevent damage during the transport. s there a sufficient securit" s"stem in place to prevent an" misappropriation of pharmaceutical products.  +re international re#uirements regarding safet" health and environmental aspects follo%ed. s procedure in place to manage damage or other event during the transit (investigation record and report to relevant authorit"). s batch trac!ing s"stem used during the transportation. s appropriate documentation accompan"ing the products during the transit. DOC+&'!%A%IO!  +re %ritten instructions or records available to document all activities relating to the distribution process. s the internal and e1ternal documentation relating to distribution process correctl" designed completed revie%ed approved and distributed.  +re all documents clear and unambiguous.  +re all documents completed approved dated and signed b" appropriate authori-ed persons.  +re the persons authori-ed to update the documentation defined. s the retention s"stem for documentation in compliance %ith national legislative re#uirements. Without specific re#uirements are the documents retained for a period e#ual to the shelf: life ? 7 "ear.

Document2

GP3453

ssue n62

7

Page n62

C of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item s there a procedure to manage the identification collection inde1ing retrieval storage maintenance disposal and access of the documentation. s there in place a suitable environment to prevent modification damage deterioration or loss of the documentation and records. s the documentation regularl" revie%ed. s there a s"stem in place to prevent inadvertent use of superseded versions of documents. s there a s"stem in place to allo% the transfer of information including #ualit" and regulator" information bet%een the manufacturer and the customer and regulator" authorit" as re#uired.  +re the records of investigations or actions concerning temperature:sensitive products retained for at least 7 "ear after the e1pir" date of the product. =or records in electronic form are the bac! ups available to prevent an" accidental data loss. #'PAC.AGI!G A!D #'A-'I!G Does the distributor perform repac!aging or labelling. f "es does the distributor have the relevant authori-ation or the licence. s the repac!aging or relabeling performed under an appropriate environment to prevent an" ris! of contamination or cross:contamination. CO&PAI!% s there a %ritten procedure to handle orall" or in %riting complaints. s there a %ritten procedure to describe the action ta!en for all information concerning a potentiall" defective or counterfeit pharmaceutical product. s each complaint investigated and documented according to a %ritten procedure. n the case of a defect is observed on a pharmaceutical product are others batches chec!ed.  +re the follo%:up actions ta!en after the investigation and the evaluation of the complaint.  +re all complaints retained to evaluate trends fre#uencies to ta!e additional and immediate corrective actions if appropriate. #'CA s there a %ritten procedure describing the s"stem in place to recall promptl" and effectivel" defective pharmaceutical products. s this procedure regularl" chec!ed and updated. s the manufacturer holder s"stematicall" informed in the event of a recall. s the effectiveness of the arrangements for recalls evaluated at regular intervals.  +re the recalled products stored in a secure and segregated area.  +re the recalled products segregated and clearl" labelled during transit.  +re the storage conditions applicable to the pharmaceutical product maintained during storage and transit before a final decision concerning the product is ta!en.  +re all customers and competent authorities informed of the intention to recall a product.  +re the records available for each recall including the name of the product the address the batch number the #uantit" recalled and the reason.

Document2

GP3453

ssue n62

7

Page n62

 of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item Does the final report of the recall include the reconciliation bet%een delivered and recovered #uantities of products. #'/'C%'D A!D #'%+#!'D P#OD+C% s there a procedure to handle the re0ected and returned products. s there a ph"sical segregation of these products in a dedicated area.  +re the storage conditions applicable to the pharmaceutical product maintained during the storage and the transit before a final decision concerning the product.  +re the nature of the product the conditions of the storage its histor" and the time elapsed since it %as issued ta!en in account in the final decision concerning the product. s the person in charge of the re0ected and returned product clearl" defined.  +re all re#uirements and relevant storage ta!en into account for the transport of returned products.  +re the products destro"ed according to national international local re#uirements and %ith due consideration to the protection of environment.  +re all returned re0ected and destro"ed records !ept. CO+!%'#0'I% PHA#&AC'+%ICA P#OD+C%  +re an" counterfeit or suspected counterfeit segregated and recorded immediatel".  +re the relevant authorities informed immediatel".  +re the products clearl" labelled to prevent distribution or sale. s the decision about the counterfeit product recorded. I&PO#%A%IO!  +t the point of entr" are the best e#uipment and the most appropriate located to handle imports of pharmaceutical products chosen.  +re the pharmaceutical products stored under suitable conditions at the port of entr". s a s"stem in place to ensure that the product s are nor mishandled or e1posed to adverse storage conditions at %harves or airports. CO!%#AC% AC%I,I%I' s a %ritten contract signed bet%een the contract giver and the contract acceptor. s the contract defining the responsibilities of each part" and observance of the principle of GDP. Do the contract givers approve all the changes before their application. s subcontracting e1isted. f "es are the conditions of subcontracting approved b" the contract giver. s the contract acceptor periodicall" audited. '01I!P'C%IO! Does the #ualit" assurance s"stem include self inspection.  +re self:inspections conducted b" independent designated and competent person.

Document2

GP3453

ssue n62

7

Page n62

E of 8

Checklist for Audit according to GDP for pharmaceutical products (WHO)

 Yes !o or !"A

Item  +re the self:inspections recorded.  +re the reports including proposals for corrective measures if necessar". s there a program of self:inspection.  +re the reports of self:inspection evaluated b" the management and corrective actions ta!en.

Document2

GP3453

ssue n62

7

Page n62

8 of 8