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Gsp china

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On January 22, 2013 the China SFDA published a Good Supply Practice guidance that will be implemented on June 1, 2013. Businesses will have a 3 year period to phase in the requirements and if this has not been accomplished by the deadline in 2016 they will be required to cease their activities. This is another demonstration that China is working diligently to upgrade the quality of their pharmaceutical manufacture and distribution networks.

The guidance significantly increases the requirements for Quality Management. The relevant chapters include: General Provisions, Drug Wholesale Quality Management, Drug Retail Quality Management, and Supplementary provisions. Significant emphasis is placed on the standards to be implemented for computerized hardware and software systems. The use of controlled computerized systems is intended to both be an aid in protection of drug quality but will also serve as a barrier to entry into this part of the pharmaceutical business.

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Gsp china

  1. 1. The new revision of “Good Supply Practice for Pharmaceutical Products was promulgated in January22, 2013. This revision contains 187 articles in 4 Chapters. There is a 3-year transition period forimplementation of newly revised GSP. The four chapters are: Chapter 1: General Principles Chapter 2: Quality Control for Wholesale Drug Chapter 3 Quality Control of Retail Drugs Chapter 4 Supplementary ProvisionsThe revision includes new requirement and systems such as Supply chain management IT-based management (facilities, network environment, database and functions of applied software) Automatic monitoring of storage temperature and humidity. Cold chain management Quality risk management, system internal evaluation and equipment validation Issuance of invoice for drug procurement and supply Shipping order and performance of inspection upon delivery for drugs distributed from warehouse Consistency among invoice, account and actual goods Examination of transportation capabilities/quality assurance and signing of quality assurance agreement with suppliers (e.g. 3rd Party Transportation)Chapter 1: General Principles These guidelines are to be implemented by Pharmaceutical operation enterprises and drug manufacturing enterprises involved in the storage and transportation of drugs in the process of drug sales and distribution. The objectives are to strengthen quality control (QC) in the distribution of drugs, regulate drug distribution activities, and ensure safe and effective use of drugs by people.Chapter 2: Quality Control for Wholesale DrugSection 1: Quality Control SystemThe aim is identification of overall quality objectives and implementation of requirementsthroughout the entire process of pharmaceutical operation. The overall objectives are: Performance/analysis of outcomes of internal evaluation for compliance to GSP and resulting continuous improvements/sustainable and effective operation of QC systems Evaluation, control, communication and verification of risk in quality during drug distribution through forecast or review. Evaluation and where necessary, site inspection of supplier’s and buyer’s QC system to confirm QA capabilities/quality reputation.Section 2: Organizational Structure and Quality control ResponsibilitiesThis section Describes establishment of organizational structure/positions, qualifications, duties, andresponsibilities, powers (e.g. authority of employee responsible for QC over drug quality issues) and
  2. 2. interrelationships (e.g. responsible person’s daily management and provision of conditions foreffective performance of QC department/personnel for achievement of quality objectives andcompliance with the GSP). Independence of QC department and performance of QC duties only byQC personnel including but not limited to: Verification of legitimacy/changes thereto of drug suppliers, buyers, purchased drugs and legal qualification of sales personnel of drug suppliers and procurement personnel of buyers Inspection/acceptance of drugs and supervision of QC activities e.g. in procurement, storage, preservation, sales, refund and transportation of drugs Confirmation/supervision of unqualified drugs Investigation, handling, and reporting of drug quality complaints/incidents/inquiry, fake/inferior drugs, recalls, and adverse drug reactions Organization of validation/qualification/calibration for relevant facilities and equipment including IT system Investigation/evaluation of QC system and service quality of suppliers and buyers Review of transportation conditions and QA capabilities of carriers Performance of internal evaluation and risk assessment of QC systems as well as QC education/trainingSection 3: Staff and TrainingThis section describes qualification requirements prescribed in relevant laws/regulations and thisGSP. Wholesale enterprise employees to include such positions as QC, inspection/acceptance and preservation/storage, procurement , employees responsible for storage and transportation of drugs under special management and drugs stored in a refrigerator or freezer whose qualification/requirements/duties are indicated. Requirements for documented pre-employment and continuing training relevant to job responsibilities/scope of work (e.g. laws & regulations, professional pharmaceutical knowledge and skills, quality control system, responsibilities & position operation procedures) Employee personal hygiene management system/gowning in such positions as storage and transportation shall meet requirements of personal protection and product protection (including those with disease that may contaminate the drugs are not to engage in activities that are in direct contact with drugs) Failing health conditions or failure to meet requirements for positions are not to engage in relevant work activities.Section 4: Quality Control System DocumentsThis section deals with the document creation/revision, review, approval, archiving, etc. followsdocument management operation procedures. QC system to include but not limited to: Qualification review for suppliers, buyers and sales personnel of suppliers, as well as employees of buyers Management of drug procurement, delivery, inspection and acceptance, preservation, sales, shipment and transportation Requirement for drugs under special management
  3. 3. Management of storage and preservation, verification, and calibration of facilities/equipment/IT system Implementation of electronic drug supervision – Departments (e.g. QC), responsible person, position for QC, procurement, delivery, receipt/shipment inspection/acceptance, storage (including records), preservation, sales/returns, transportation, finance, and information management/IT system job responsibilities and requirements for operating procedures/records/traceability of such processes are described.Section 5: Facilities and EquipmentThis section deals with the requirements of business site/warehouse commensurate with scope ofdrug business operation.Documented site selection, design, layout (including zoning for different operations/purpose),construction, upgrade and maintenance/cleaning/inspection of warehouse/facilities shall meet therequirements on drug storage (i.e. reasonable/safe- e.g. security/limited access to avoid theft orreplacement of drugs/mixture of counterfeit drugs, prevent impact of extreme weather conditions,dedicated storage sites, use of appropriate equipment/automatic monitoring/recording/alarmdevices e.g. for refrigerators/freezers including those for transportation vehicle, etc.) and avoid drugcontamination, cross-contamination, confusion and mistake.Section 6: Calibration and VerificationThe requirements for the performance of verification (pre-use and continuing) and calibration offacilities/equipment e.g. refrigerator/freezer including those for transportation vehicle and use in aproper and reasonable manner in accordance with verified parameters and conditions has beendescribed.Section 7: IT systemThis section deals with the establishment of IT system considering drug quality traceability and meetconditions for the implementation of electronic drug supervision and meet the followingrequirements but not limited to: Server and terminal to support the system’s normal operation supported by secured and stable network environment, landline Internet access/reliable information platform, local area network , and applied software/relevant database including functionality e.g. generation, printing and management of pharmaceutical operation business invoice Operations (including corporate operation/management) e.g. data entry/editing/saving) consistent with the requirements on the scope of authorization, operating procedures and management systems to ensure the originality, truthfulness, accuracy, security and traceability of data including secured storage and backupSection 8: ProcurementProcurement activities to include but not limited to the following requirements: Confirmation of supplier’s legal eligibility & legitimacy of purchased drugs Verification of legal qualification of sales employees of suppliers Signed QA Agreements with suppliers (including responsibilities of both parties, and www.Rxdrug transportation, and site inspection/evaluation of QC system)
  4. 4. Requirements (including required relevant documentation/record retention) for firsttime suppliers, initially handled drugs, drugs under special management involved in procurement are identified thereto Documentation/evaluation/record retention requirements for procurements of drugs (e.g. invoice and required data) and procurement in the event of special situations (e.g. disaster, etc.) are identified thereto Requires periodic comprehensive quality evaluation for the overall situation of drug procurement, drug quality evaluation and supplier quality records, and dynamic follow-up managementSection 9: Receiving and Inspection of GoodsThe objective of this section it to prevent entry of unqualified drugs via receipt inspection accordingto procedures/requirements (including verification of information concerning mode oftransport/conditions e.g. temperature/duration, shipping order, representativesampling/acceptance/rejection, etc.).Section 10: Storage and PreservationRequirements for proper storage of drugs to meet the following but not limited to: Appropriate temperature and humidity requirements or those prescribed in Pharmacopoeia of the People’s Republic of China Special storage handling requirements (e.g. color labeling for manual warehouse, stacking/placement, protection and shade from light, ventilation, moisture prevention, including insect and rat prevention) Cleanliness of storage area (including facilities/equipment and limited access into storage areas– Preservation of drugs ( e.g. according to warehouse condition, external environment, etc.) and storage of questionable drugs under lock/recorded in IT system including automatic tracking/control of shelf life of warehoused drugs Prevention/protection from contamination including handling/storage/documentation/disposition/preventive measures for suspicious/drugs with quality problems Periodic inventory/reconciliation of drugsSection 11: SalesDrugs are sold legitimate buyers (verified proof documents, identity proof of procurement anddelivery personnel to ensure truthful/legitimate flow of drug sales and issues sales invoice to ensureconsistency among invoice, account, goods and fund and keep records of drug sales havingappropriate information listed theretoSection 12: Drug Distribution from Warehouse Drug distribution from warehouse are verified versus sales record and are prohibited/reported to QC department for defects (e.g. damaged, contaminated, leakage, labelling defects, expired, other abnormal conditions) Verification records (with appropriate information listed thereto) of distribution of drugs (including drugs under special management verified according to relevant regulation) are established as required Consolidated shipment will be labelled as such (on package containers)
  5. 5. Shipping order/ticket of original stamp for drug distribution from warehouse are attached, special provisions provided for direct delivery of drugs Container/truck loading operations, etc. of refrigerated or drugs stored in freezer are carried out under supervision of assigned personnel and meet requirements identified thereto (e.g. meeting/inspected for corresponding temperature requirements and transportation recorded with appropriate information) Conduct code scanning and data uploading for drugs subject to electronic supervisionSection 13: Transportation and Delivery Execute transportation operation procedures as required by QC system to ensure drug quality and safety (including those drugs under special management) Transport vehicles are identified and appropriate for drug packaging, quality attributes and control requirements to prevent problems (e.g. damage and contamination) and are monitored on real-time basis as appropriate (e.g. for temperature). Emergency plan are available/applied (e.g. during equipment failure, abnormal weather) occurring during transportation Where applicable, entrusted drug transportation entity shall be audited for QA capabilities/other relevant information about transport vehicles/meeting prescribed requirements for transport facilities and equipment, and a transportation agreement generated/record kept (min 5 years) clarifying responsibilities and compliance to transport operation procedure/estimated time en-route and other relevant transportation information and requirements (e.g. delivery time and address, transport mode, shipped/delivered after loading, etc.) Transportation security management measures are employed to prevent incidents (e.g. theft, loss, counterfeiting)Section 14: After-sales ManagementIncludes management (e.g. handling, appropriate notification/reporting, documentation, evaluation,monitoring, etc.) of returned goods, complaints, recalls, and adverse drug reactionsChapter 3 Quality Control of Retail DrugsSection 1 Management DutiesIncludes but not limited to: Development/implementation of QC system/documents, appropriate operational conditions/organizational structure, personnel, facilities and equipment, and IT system Responsible persons major responsibilities for quality of drugs sold, corporate day-to-day management including provisions of appropriate conditions for effective fulfillment of duties for QC department/personnel and compliance with the GSP including but not limited to: Review/qualification of suppliers and their sales employees Review legitimacy of purchased drugs Performance of inspection/acceptance of drugs and oversee QC activities (e.g. drug procurement, storage, display and sales) Management (e.g. handling, appropriate notification/reporting, documentation, evaluation, monitoring, etc.) of drug quality inquiry/information, complaints/incidents, unqualified drugs, counterfeit/inferior drugs, and adverse drug reactions, and pharmacological service activities
  6. 6. Review/conduct/organize QC education/training, IT systems operation authority/maintenance of basic QC data, and calibration/verification of measuring instrumentsSection 2: Personnel Management Legal representative/responsible person is a licensed pharmacist – Quality control, inspection, acceptance and procurement, and sales personnel possesses qualification requirements indicated thereto Establish training management system and employees to receive documented relevant pre- employment and continuing training as indicated theretoSection 3: Documentation Establish QC documents (e.g. QC systems, job responsibilities, procedures, etc.), properly understood/effectively implemented, reviewed and timely revised QC system to include but not limited to: o Review of suppliers and drug products for procurement o Management of drugs under special management/drugs subject to separate national management requirements, records and certificates, collection/inquiry of quality information, quality incidents/complaints, IT system, electronic drug supervision, etc. o Clarify responsibilities of corporate responsible persons and other positions (including storage and preservation positions/procedures where a warehouse is established) o Duties of QC and formulation review positions are not performed by personnel of other positions on their behalf o Drug retail operation procedure to include but not limited to: o Procurement, inspection, acceptance and sales of drug products o Refrigerated storage of drug products o Operation/management of IT system (security/authorization, accuracy, back up, etc.) o Establishment of relevant records/records retention (minimum 5 years)Section 4: Facilities and Equipment Business location compatible with scope and scale of drug operation, separate from areas for drug storage, office work, utility area and other areas and have proper facilities/other effective measures in place to prevent the impact of outdoor environment on drug products and be spacious, bright, tidy and clean and have business equipment listed thereto Establishment of IT system in line with requirements of business operation/QC meeting conditions for the implementation of electronic drug supervision If retail enterprise has a warehouse, it should meet the requirements and have facilities and equipments as described thereto (including special warehouse for traditional Chinese medicine preparations and calibration/verification of measuring and monitoring instruments/equipment)Section 5: Procurement, Inspection and Acceptance Compliance with relevant Chapter 2 Section 8: Procurement (drug products) of GSP
  7. 7. Conduct/handling of drug product receipt, verification/representative sampling/inspection/acceptance/rejection/documentation/reporting as per prescribed procedures/requirements thereto (ensuring consistency among shipping ticket, account and actual goods including drug products under special management and those subject to electronic supervision)Section 6: Display and Storage Requires monitoring, control and compliance to room temperatures (business venues) Requirement for periodic hygiene inspection and cleanliness of equipment for storage and display of drug products including measures (e.g. insect and rat prevention) to prevent contamination to drug products Display, inspection/reporting/documentation (on display and storage) of drug products shall meet requirements as described thereto Tracking of drug product shelf life to prevent possible use of expired/near shelf-life drugs Compliance to relevant provisions of Chapter 2 Section 10 of the GSP (if retail enterprise has established warehouse)Section 7: Management of Sales Requirements for display of Drug Operation License, Business License, Registration Certificate of Licensed pharmacists, etc. to visible locations of its business venue Compliance to proper identification of sales person/signboard indicating licensed pharmacists on duty Compliance to requirements for sales of drugs as indicated thereto Issuance/documentation of sales invoice with appropriate information and sales record Compliance to requirements of retail sale of drug products as identified thereto Compliance to requirements/national regulations for drugs under special management and drug advertising Prohibition of sale of drugs by non-retail enterprise employees Required scanning of codes and data upload upon sale for drugs subject to electronic supervisionSection 8: After-sales Management Other than quality reasons, no drug product refund or replacement after sale Requirement for display of supervision hotline of drug administration department at its business location, establish a customer feedback book and timely handling of customer complaints on drug quality. Collection and reporting of adverse drug reactions and after-sales drug product quality problems in accordance with national regulation including assisting drug manufacturers for recall (e.g. documentation/record and reporting to drug administration department), as applicableChapter 4 Supplementary Provisions Compliance to relevant regulations (drug wholesale or retail) GSP prescribes basic requirement on the QC of drug operation. Other specific requirements are stipulated by SFDA through appendices (e.g. IT-based corporate management, management of drug cold chain logistics, etc.)
  8. 8. Provision of Definitions of terminologies in the GSPNon-compliance of drug operation enterprise against this GSP is punishable by drugadministration departments in accordance with Article 79 of Drug Administration Law of thePeople’s Republic of China

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