Transcription

PHARMACEUTICAL INDUSTRYRECORD OF TRAINING AND EXPERIENCE OFPROVISIONALLY REGISTERED PHARMACIST(PRP)PHARMACY BOARD MALAYSIAMINISTRY OF HEALTH MALAYSIA

Pharmaceutical IndustryPERSONAL PARTICULARS[To Be Completed By the Provisionally Registered Pharmacist (PRP)]1.Name (in capital letters) :2.New I/C Number3.Provisional Registration Number:4.Telephone Numbers:5.Home Address:6.E-mail Address:7.Qualification (Degree/ University/ Year):8.Scholarship/Sponsor (Federal/MARA/Others):9.Principal Training Place:10.Duration of Training: From (date): . to 11.Name & Contact Number of person in case of emergency::I confirm that the above information provided above is true.Signature:Pharmacy Board Malaysia 2012Date:Page 2

Pharmaceutical Industry1. INTRODUCTION1.1The Registration of Pharmacists Act (Amendment) 2003 stipulates that aperson who is provisionally registered shall be required to obtain experienceimmediately upon being provisionally registered, engage in employment as aProvisionally Registered Pharmacist (PRP) to the satisfaction of the PharmacyBoard for a period of not less than one year.1.2The engagement as a PRP must be in any premises listed in the SecondSchedule in order to be entitled to apply for full registration.1.3The Pharmacy Board may extend the one year period of employment of aPRP if the Board is not satisfied with the performance of that person as aPRP.1.4The provisional registration of a person shall be revoked if that person fails toengage in employment as a PRP to the satisfaction of the Pharmacy Board fora period of not less than one year in any premises listed in the SecondSchedule.1.5All PRPs are required to pass the Pharmacy Jurisprudence Examinationconducted by the Pharmacy Board prior to full registration.Pharmacy Board Malaysia 2012Page 3

Pharmaceutical Industry2.TRAINING MODULES AND RECORD OF TRAINING ANDEXPERIENCE OF THE PROVISIONALLY REGISTEREDPHARMACIST [PRP] IN PHARMACEUTICAL INDUSTRY2.1Preamble:2.1.1The pharmaceutical manufacturing industry is an emerging industry thatrequires specific sets of people competencies to align with the nature andchallenges faced, internally and externally, by the industry.2.1.2 By the end of the training, the PRP will be able to achieve key and functionalcompetencies in the aspect of manufacturing sector. This shall then presentdiversity in the role, experience and contribution of the pharmacists inMalaysia.2.2Objective:The training of pharmacists in the manufacturing sector aims to provide thepharmacists with sufficiently in-depth clarity in the understanding of themanufacturing of pharmaceutical products and to equip the pharmacists withrelevant knowledge and skills required in the industry.2.3This record book is designed primarily to guide the provisionally pharmacistsand their preceptors of various pharmacy disciplines in the training institutionin coordinating activities and programs during the one-year provisionaltraining.2.4This record book will be used for the purpose of appraisals by the PrincipalPreceptors and Master Preceptor, and will be submitted to the PharmacyBoard for the registration of the PRP as a fully registered pharmacist.2.5There are 6 main modules of training for the provisionallyregistered pharmacist [PRP] in the pharmaceutical industry;2.5.1 Production Process: Manufacturing and Packaging of PharmaceuticalProducts2.5.2 Logistics, Warehousing and Distribution of Pharmaceutical Products2.5.3 Regulatory AffairsPharmacy Board Malaysia 2012Page 4

Pharmaceutical Industry2.5.4 Research & Development/ Technical Services OfPharmaceutical Products2.5.5Quality Assurance / Quality Control / Stability / Validation ofPharmaceutical Products2.5.6 Sales & Marketing of Pharmaceutical Products2.6The PRP is required to provide the following information;2.6.1 Name, I/C Number, Name of Institution and period of training and allother requested information in this book.2.6.2 Date of task completed and evidence of proof for each section/unit ofattachment.(If the columns indicated are insufficient, please use an additionalattachment.)2.6.3 Each evidence given is to be endorsed by the immediate preceptor ofthe section/ unit.2.7The preceptor is required to complete the record by filling thefollowing;2.7.1 Endorse the completion of each task with signature, name anddate in the column provided.2.7.2 Level of performance is based on the following scale;1unsatisfactory2satisfactory3good4excellent orN/A Not applicableThe passing mark is 60 % for every section and the sum total of all theunits.Pharmacy Board Malaysia 2012Page 5

Pharmaceutical Industry2.7.3 The final appraisal is to be completed by the Master Preceptor at the11th month of the training period and to be sent to;Lembaga Farmasi MalaysiaBahagian Perkhidmatan FarmasiKementerian Kesihatan MalaysiaBeg Berkunci No.924,Pejabat Pos Jalan Sultan46790 PETALING JAYA2.8Criteria of Manufacturing Facility for Training of PRP2.8.1 All Pharmaceutical Manufacturing Facilities, excluding thosepharmaceutical manufacturers of Traditional Medicines and HealthSupplements.2.8.2 Pharmaceutical manufacturing facilities must meet current GoodManufacturing Practice (cGMP) requirements and have a validManufacturing License issued by the Drug Control Authority (DCA) forthe current year.2.8.3 Manufacturing Facilities shall have Principal Preceptors and a MasterPreceptor qualified and appointed by the manufacturing facility; andapproved by the Pharmacy Board.Pharmacy Board Malaysia 2012Page 6

Pharmaceutical Industry3. DUTIES AND RESPONSIBILITIES OF A PRECEPTOR3.1Type of preceptorsPrincipal Preceptor:Head of Department, not necessarily aregistered pharmacistMaster Preceptor:Plant / Manufacturing Head/ Quality AssuranceManager must be a registered pharmacist.[Criteria of a preceptor: A Master Preceptor must have at least 4 years of practicalexperience in the pharmaceutical industry and a Principal Preceptor must have atleast 3 years’ experience in the respective department.]3.2Responsibilities Of A Preceptor3.2.1 To serve as a learning resource for the PRP. Ensuring the PRP receivesnecessary training to develop skills and behaviors expected as acompetence pharmacist in the pharmaceutical manufacturing industry.3.2.2 To answer PRP queries or direct the PRP to the appropriate referencesand/or show them areas of learning still to be covered.3.2.3 To serve as a role model instilling professional values and attitudes and toexplain to the PRP reasons for your actions when called upon to makeprofessional judgments.3.2.4 To attempt in providing a full range of professional advice and guidance;and to provide positive and corrective feedbacks during the training/learning process.3.2.5 To assess PRP performances or delegate some of the assessment toanother suitable person and to discuss the PRP strengths andweaknesses.Pharmacy Board Malaysia 2012Page 7

Pharmaceutical Industry4.DUTIES AND RESPONSIBILITIES OF A PROVISIONALLYREGISTERED PHARMACIST [PRP]Being a Provisionally Registered Pharmacist [PRP], you should;4.1At all-times comply with the directives and orders given to you by the departmenthead.4.2Aim to become a competent registered pharmacist by the end of theperiod.4.3Undertake the training modules/ program with a positive attitude and acommitment to learn from the preceptor and other staff in the trainingenvironment.4.4Remember that obtaining adequate working experience is your responsibility.Others will help, but it requires a conscientious effort on your own part, not justpassive acceptance.4.5Recognise that not all of the preceptor’s time can be devoted to teaching, andyou should therefore actively acquire knowledge and skills by observation,reading and questioning others.4.6Be aware that, in addition to the daily activities, your time should be set aside toconsider activities outside working/office hours.4.7Always actively participate in professional development as it is essential to buildon your undergraduate studies and keep abreast of current knowledge.4.8Be aware that; the Certificate of Satisfactory Experience, required underSection 6A(2) Registration of Pharmacists Act (Amendment) 2003 willonly be issued to you if;(i)(ii)trainingYou have passed the Pharmacy Jurisprudence Exam which will beconducted by the Pharmacy Board in March/June/November.[Please inform your immediate preceptor if you wish to sit for thetest at least a month earlier]The average passing mark of your training performance must be at least60% for each section and the sum total of all the units.Pharmacy Board Malaysia 2012Page 8

Pharmaceutical Industry4.9Overview Of Competencies Training Schedule:During the entire training duration, the PRP will be placed in the coreDivisions/Departments in the Company under the guidance and supervision ofthe Department/Division Head and supervised overall by a Master Preceptor.The duration of training in each module is as indicated inTable 1.1.Mini project where indicated under the different modules are optional but it will bein the interest of the PRP to be given at least ONE (1) mini project throughout theperiod of training.Table 1.1: Training Time-tableDuration(Weeks)COMPETENCY TRAINING MODULES22PRODUCTION PROCESSES : THE MANUFACTURING ANDPACKAGING OF PHARMACEUTICAL PRODUCTSLOGISTICS, WAREHOUSING AND DISTRIBUTION OFPHARMACEUTICAL PRODUCTS4REGULATORY AFFAIR : REGISTRATION PROCEDURES, POSTREGISTRATION ACTIVITIES AND RELATED LICENCES OFPHARMACEUTICAL PRODUCTS4RESEARCH & DEVELOPMENT OF PHARMACEUTICAL PRODUCTS8QUALITY ASSURANCE / QUALITY CONTROL / STABILITY /VALIDATION OF PHARMACEUTICAL PRODUCTS12SALES & MARKETING OF PHARMACEUTICAL PRODUCTS2TOTALPharmacy Board Malaysia 201252Page 9

Pharmaceutical Industry5. RECORD OF TRAINING AND EXPERIENCESPharmacy Board Malaysia 2012Page 10

Pharmaceutical ING OF PHARMACEUTICAL PRODUCTSAND(Duration of Attachment: 22 weeks)1.Knowledge and the understanding of the principle of production process planningand structure of the organization.2.Familiarity with terminology, guidelines and specification related to manufacturingaccording to PIC/S cGMP, ISO Certification and ICH documents.3.Knowledge of Standard Operating Procedures (SOPs) and ability to adhere tothe SOP during operation.4.Knowledge of master formula, production record and their contents,manufacturing techniques, use and selection of appropriate equipment, shelfsample, and product release procedures etc.5.Knowledge and understanding cleaning, sanitization, safety and security inproduction process.6.Knowledge of the manufacturing of various dosage forms of products eithersterile or non-sterile (e.g. tablets, capsules, soft-gels, creams, liquids, injectables,whichever is/ are manufactured in the plant) including: the properties of ingredients used in the manufacturing process;manufacturing processes and machinery employed in various dosage forms;knowledge of essential & critical utilities used in manufacturing plant;the properties of various dosage forms;the packaging of finished products, including stability characteristics andstorage requirements;understanding of the principles of Good Manufacturing Practices (GMP)7.Knowledge on master planned preventive maintenance, risk management incontrolling cross contamination and the implications.8.Knowledge on validation in production process.Pharmacy Board Malaysia 2012Page 11

Pharmaceutical IndustrySECTION 1:PRODUCTION PROCESS PLANNINGLevel of PerformanceNo.Knowledge/TaskComments11Attending the briefing session.2Able to understand structure/ layout andidentify own role in the A(MPS, MRP, MOQ, JIT etc)5Able to translate MPS to weekly productionplanning.Quantity:6Able to understand the basic component ofERP systems, how it works and the benefits7Ability to deliver good presentation (optional)Pharmacy Board Malaysia 2012Page 12Name andSignature ofPreceptor

Pharmaceutical IndustrySECTION 2:SYSTEM AND PROCEDURE MANAGEMENTLevel of PerformanceNo.Knowledge/TaskComments11Attending the briefing session.2Knowledge on preparation of standardoperating procedures (SOP’s) and adheringto standard operating procedures n and controlling SOP’s4Understandingofguidelinesandspecifications related to manufacturingaccording to PIC/S cGMP, ISO certifications& ICH documents.5Knowledge on cleaning, sanitization and thedifferences between them6Knowledge on different type of cleaningagents used: detergent, solvent cleaners,acid cleaners and abrasive cleaners.Pharmacy Board Malaysia 2012234NAstorage,Page 13Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments1 234NAAble to prepare cleaning agentsQuantity :7Knowledge on different sanitizing terms:antiseptic, disinfectant, bactericide, etc anddifferent sanitization method: chemical, heatand radiation. Perform sanitization and microbialsamplingQuantity :8Knowledge onmanagement facilityandequipmentPerformreplacementconsumable partsfor9Knowledge on equipment master list and itsfoot print.10Knowledge on master planned preventivemaintenancePharmacy Board Malaysia 2012Page 14Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments111Knowledge on risk managementcontrolling cross on:patientsafety,reputation13Knowledge of role of production in Validation(Process, Cleaning, Machine Qualification understanding of URS, DQ, IQ, OQ and PQ) 234NAincrosscost,Assist in validation/qualificationprocess and report preparation14Knowledge and skill on preparing UserRequirement Specification (URS)15Knowledge on “V” model and its applicationin validation16Knowledge on the difference and applicationof prospective, retrospective and con-currentvalidation.Pharmacy Board Malaysia 2012Page 15Name andSignature ofPreceptor

Pharmaceutical IndustrySECTION 3:CORE MANUFACTURING PROCESSKnowledge of the function and purpose of productionLevel of PerformanceNo.Knowledge/TaskComments11Attending the briefing session.2Abletoexplaintheobjectivesmanufacturing function and processes.3Knowledge on the differences of sterile andnon-sterile products.4Describe the meaning of the main terms usedin production.5Knowledge on main production operations,critical pathways for each process and controlfunctions.6Knowledge on process flow for differentdosage form Formula calculation in BMR pH adjustment Perform IPQC checkingPharmacy Board Malaysia 2012234NAofPage 16Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of hetechnologyandfunctionality of each machine/equipment usedin each process, such as : Mixer, Granulator/Oscillator, FBD, Oven, IBC, One-PotProcess, Compression machine, etc.8Knowledge on essential & critical utilitiesused in manufacturing plant: Plant steam,Pure steam, HVAC system, Compressed air,Vacuum system, Waste Water treatmentPlant, Dust extractor and Water System.9Knowledge on the role of each critical utility inthe operation tions of the different utilities indifferent types of manufacturing facility.11To comprehend the technical knowledge oncore production processes: ing, Capsulation, Blistering, etc.Pharmacy Board Malaysia 2012234NAPage 17Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/Task112234CommentsName andSignature ofPreceptorCommentsName andSignature ofPreceptorNAKnowledge of and perform yield calculationand re-conciliation.Sterile ProductionLevel of PerformanceNo.Knowledge/Task11Knowledge on defining sterile product2Knowledge on the differences betweenterminally sterilized product and asepticproduct3Knowledge on Sterility Assurance program4KnowledgetechniqueonapplicationPharmacy Board Malaysia 2012of234NAasepticPage 18

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments15Knowledge on different grade of clean room,its specification and qualification of cleanroom6Knowledge on personnel qualification7Knowledge on the critical parameters tomonitor in clean room:234NATemperature, humidity, differential pressure,air flow velocity, air flow rate, air borneparticulate count, air change rate, air flowdirection,HEPAfilterleakagetest,containment test, recovery test.8Knowledge on gowning procedure and ableto demonstrate adherence to procedure9Able to demonstrate understanding onaseptic technique during broth evaluationstudy10Knowledge on production process flow insterile production area: Washing, Dispensing,Compounding, Filtration, Filling, Leak testing,Inspection, Labeling and Cartoning.Pharmacy Board Malaysia 2012Page 19Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments111Knowledge on the technology used in eachprocess step.12Knowledge on different sterilization method,advantages and disadvantages of eachsterilization method and validating theprocess.13Knowledge on de-pyrogenation and validationof the process14Knowledge on specific requirement forutilities used in clean room: Pure steam, WFI,Compressed air, Pharmaceutical Gasses,HVAC system15Knowledge on sterility testing16Knowledge on microbiological environmentalmonitoring 17234NAPerform samplingKnowledge on media fillPharmacy Board Malaysia 2012Page 20Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments118Knowledge on Blow fill and seal technology(container moulding, container filling andcontainer sealing)19Knowledgeontheapplicationadvantages of using BFS technology.SECTION 4:234NAName andSignature ofPreceptorandPROCESS DOCUMENTATION IN MANUFACTURINGLevel of dge on preparing documentation BMR / BPR, SOP, Status Labels Drafting new document Reviewing SOP and BMRKnowledge of the content and importance ofBMR/BPR: traceability etc.Pharmacy Board Malaysia 2012Page 21Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of e on status labels and why it’sused. 42Ascertain correct label for ionandmanagementofControlled Drugs & Import / Export Permit.(Referring to Poison Act etc) Recording of Controlled Drugstransactions5Knowledge on the process flow in handlingof Controlled Drugs & Import / Export Permit6Knowledge on the role of pharmacist onhandling of controlled drugs7Ability to deliver good presentation (optional)Pharmacy Board Malaysia 2012Page 22Name andSignature ofPreceptor

Pharmaceutical IndustryGENERAL COMMENT ON ATTITUDEMark x 100%244 %Preceptor’s Name & Signature:Date:NOTE:1. If the service is not available in the industry, the Principal Preceptor/ Head of Pharmacists in the organisation therefore hasright to transfer the PRP to other units/ sections.2. % mark should not less than 60% for every units/ sections.Pharmacy Board Malaysia 2012Page 23

Pharmaceutical IndustryLOGISTICS,WAREHOUSINGPHARMACEUTICAL PRODUCTSANDDISTRIBUTIONOF(Duration of Attachment: 4 weeks)1.Knowledge and understanding of the principles of store management,inventory, stock movement and control, cleanliness and sanitation andsecurity in accordance to Procedures in Store Management.2.Knowledge of storage and distribution of biological, handling ofcytotoxic drugs, refrigerated items, inflammables and corrosive items,safety measures, maintenance of cold chain on transit and storage inaccordance to Good Storage Practice (GSP) and Good DistributionPractice (GDP).3.Knowledge of disposal procedures and its documentation.4.Knowledge of recall management according to procedures andregulatory requirements.5.Knowledge on handling of returned, damaged, spilled products andexpired stocks according to procedures and regulatory requirements.6.Knowledge of the statutory aspect related to storage and distribution ofmaterials, drugs and finished products in accordance to the respectivelegislations:7. Dangerous Drugs Act 1952 & its Regulations Poisons Act 1952 & its Regulations Poisons (Psychotropic Substance) Regulations 1989Knowledge andtransportation.Pharmacy Board Malaysia 2012understandingthemanagementofgoodsPage 24

Pharmaceutical IndustrySECTION 1:OVERVIEW OF LOGISTIC, WAREHOUSING AND DISTRIBUTIONLevel of ation Structure/Layout/ ChartAble to understand structure/layout andidentify your role in the organization2InventoryAwareness of Store Catalogue and type ofproducts managed.3Stock Movement And ControlAble to explain stock movement and controlof drugs and non-drugs4CleanlinessAble to identify requirements5Security/ SafetyAble to list security/safety aspects of store6Pest ControlMonitor pest control activities with contractorPharmacy Board Malaysia 2012Page 25Name andSignature ofPreceptor

Pharmaceutical IndustrySECTION 2:SUPPLY CHAIN AND INVENTORY MANAGEMENTLevel of PerformanceNo.Knowledge/TaskComments11Able to understand what is meant byinventory and the importance of it.2Able to understand demand and supply insupply chain and procurement managementfor manufacturing needs3Knowledge on supplyprocess integration4Able to manage inventory in the supply chain5Able to identify the major challenges toeffective supply chain strategy6Able to understand the basic principlesbehind the quantitative approach on decidinghow much inventory to keepPharmacy Board Malaysia 2012chain234NAbusinessPage 26Name andSignature ofPreceptor

Pharmaceutical IndustrySECTION 3:STORAGE AND DISTRIBUTION OF PHARMACEUTICAL PRODUCTSLevel of PerformanceNo.Knowledge/TaskComments11234NAGood Storage Practice (GSP) and GoodDistribution Practice (GDP)Able to understand GSP and GDPrequirements and key principles to storageconditions, stock discrepancies and stockdisposal management2Able to understand the management ofeffective stock levels in prevention ofbackorders or over stocking3Able to conductreceiving of stocksthefollowingduring Weighing and counting of receivedstocks Visual inspection Verifying documents (COA, DO vsPO)Pharmacy Board Malaysia 2012Page 27Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments1434NAStock Movement Management Able to allocate stocks based on FIFO Preparation of stocks for productionneed – weighing/counting/packing/etc Cleaning down of stock containersprior to entrance into production bufferarea5Knowledge on the requirement of storageand documentation relating to speciallycontrolled items.6Knowledge and understanding the need of acycle-count and stock take 72Conduct an actual exercise frominvolvement in preparatory work toinvolvement in generation of finalreportAble to understand the implementation ofproper segregation, markings at designatedareas within the warehouse. Product storage in appropriate areasbased on statusPharmacy Board Malaysia 2012Page 28Name andSignature ofPreceptor

Pharmaceutical IndustryLevel of ge on requirements of certain itemswith temperature and humidity control needs. Temperature and humidity monitoringPharmacy Board Malaysia 2012Page 29Name andSignature ofPreceptor

Pharmaceutical IndustrySECTION 4:STOCK MANAGEMENT ACCORDING TO STATUTORY REQUIREMENTSAND STANDARD PROCEDURESLevel of PerformanceNo.Knowledge/TaskComments11Knowledge on the relevant legislation in theeffective management of scheduled drugsand controlled medicines.2Knowledge on documentation requirementsand compliance to various legislation suchas Poison Act, Dangerous Drugs Act, andSale of Drugs Act and Control of Drugs andCosmetic Regulations3Knowledge of recall management includingstorage & disposal according to proceduresand regulatory requirements4Handling of returned, damaged, spilledproducts and expired stocks and theirappropriate storage & disposal according cy Board Malaysia 2012234NAPage 30Name andSignature ofPreceptor

Pharmaceutical IndustrySECTION 5:MANAGEMENT OF TRANSPORTATIONLevel of PerformanceNo.Knowledge/TaskComments11Able to understand the selection of vendorfor transportation of finished goods2Continuous education on GDP with transportvendors3Understand the significance of stackingorientation during uploading of goods ontotransportPharmacy Board Malaysia 2012234NAPage 31Name andSignature ofPreceptor

Pharmaceutical IndustryGENERAL COMMENT ON ATTITUDEMark x 100%108 %Preceptor’s Name & Signature:NOTE:1. If the service is not available in the industry, the Principal Preceptor/ Head of Pharmacists in the organisation thereforehas right to transfer the PRP to other units/ sections.2. % mark should not less than 60% for every units/ sections.Pharmacy Board Malaysia 2012Page 32

Pharmaceutical IndustryREGULATORY AFFAIRS: REGISTRATION PROCEDURES, POSTREGISTRATION ACTIVITIES AND RELATED LICENCES OFPHARMACEUTICAL PRODUCTS(Duration of Attachment: 4 weeks)1.Knowledge and understanding the essential functions andcore activities of the Regulatory Affairs Department.2.Knowledge of the statutory aspect relating to registration,clinical testing, post registration and document controls.3.Knowledge on the importance of being updated on everchanging legislation in all the regions in which theorganization wishes to distribute its products.4.Knowledge and understanding on the legal and scientificrestraint and requirement.Pharmacy Board Malaysia 2012Page 33

Pharmaceutical IndustrySECTION 1:REGISTRATION PROCEDURESLevel of PerformanceNo.Knowledge/TaskComments11Knowledge on regulatory guidelines ofMalaysia and ASEAN for Ethical Drugs,OTCs, Health Supplements, TraditionalMedicines and Cosmetics2Knowledge on International RegulatoryGuidelines for Pharmaceuticals such asICH, WHO, EMA & FDA3Labeling,PackageInsert,PatientInformation Leaflet (PIL) requirements234NAAble to investigate product history of similarproducts to assess approval implicationsQuantity :Able to conduct research on submissionrequirements and optionsQuantity :Knowledge on requirement of HologramPharmacy Board Malaysia 2012Page 34Name and Signatureof Preceptor

Pharmaceutical IndustrySECTION 2:POST REGISTRATION ACTIVITIESLevel of PerformanceNo.Knowledge/TaskComments11Able to comprehendMalaysia2Knowledge in renewal procedure of productlicences in Malaysia3Able to assist in the preparation of routinereportsandregulatoryagencycommunications thevariations34NAinCommunication Log4Able to assist in the review of advertising andpromotional items5Able to coordinate internal audits andinspection6Able to assist in the preparation of postmarket reports and submission7Knowledge on tracking product events,complaints and recalls 2Awareness on counterfeit issuesPharmacy Board Malaysia 2012Page 35Name and Signatureof Preceptor

Pharmaceutical IndustrySECTION 3:INFORMATION MANAGEMENT AND CONTROL IN REGULATORY AFFAIRSLevel of PerformanceNo.Knowledge/TaskComments11Knowledge on transfer information ofregistered product to the manufacturingfacility2Knowledge on database management ofsubmitted dossiers to the authority234NAParticipate in product and/or regulatoryteams to coordinate documentationMaintain records to comply with regulatoryrequirementsComposeroutineregulatory agenciescorrespondenceto3Respond to RA information requests4Able to interact with outside experts, partnersand regulatory agencies, as requested5Able to assist in preparation for technicalmeetings with regulatory agenciesPharmacy Board Malaysia 2012Page 36Name and Signatureof Preceptor

Pharmaceutical IndustryLevel of PerformanceNo.Knowledge/TaskComments16234NAAble to maintain records on legislation,regulation and guidelinesPharmacy Board Malaysia 2012Page 37Name and Signatureof Preceptor

Pharmaceutical IndustrySECTION 4:RELATED LICENSING ACTIVITYLevel of PerformanceNo.Knowledge/TaskComments11234NAAble to demonstrate understanding of thefunctions and activities of the RA departmentin application for Manufacturer’s Licence,Import Licence and other required licencesAble to prepare licence applicationPharmacy Board Malaysia 2012Page 38Name and Signatureof Preceptor

Pharmaceutical IndustryGENERAL COMMENT ON ATTITUDEMark x 100%92 %Preceptor’s Name & Signature:NOTE:1. If the service is not available in the industry, the Principal Preceptor/ Head of Pharmacists in the organisation thereforehas right to transfer the PRP to other units/ sections.2. % mark should not less than 60% for every units/ sections.Pharmacy Board Malaysia 2012Page 39

Pharmaceutical IndustryRESEARCH & DEVELOPMENT/TECHNICAL SERVICES OFPHARMACEUTICAL PRODUCT(Duration of Attachment: 8 weeks)1. Understanding of Research & Development functions in thecompany.2. Understanding on Patent/Intellectual Properties/Data Exclusivity inPharmaceutical Industry.3. Understanding of pre-formulation, formulation, development andproduct improvement of various pharmaceutical dosage forms.4. Ability to conduct Experimental Formulation Development.5. Understanding on Bioequivalence Study design and overall conductof study.6. Understanding on method development and validation for newformulation.7. Ability to design and conduct stability study in drug developmentprocess.8. Ability to write a Pharmaceutical Development Report.9. Activities’ involves in this department are: Mini project on new product/product improvement formulationConduct literature searchExcipient incompatibility study in formulationConduct laboratory batch experimentsConduct pilot batch experiments(optional)Conduct Physical/Chemical/Microbiology analysisData analysis reportingPharmacy Board Malaysia 2012Page 40

Pharmaceutical IndustryASSESSMENTLev

Pharmaceutical Industry Pharmacy Board Malaysia 2012 Page 5 2.5.4 Research & Development/ Technical Services Of Pharmaceutical Products 2.5.5 Quality Assurance / Quality Control / Stability / Validation of Pharmaceutical Products 2.5.6 Sales & Marketing of Pharmaceutical Products 2.6