GMP Compliance Checklist Template
GMP Compliance Checklist Template
Use this template to conduct a self-inspection within the company in order to comply with the EU Gross Distribution Practice (GDP) at all time.
GMP Compliance Checklist Template
Use this template to conduct a self-inspection within the company in order to comply with the EU Gross Distribution Practice (GDP) at all time.
Related categories
Preview of the template
Quality System
Quality manual or equivalent documentation approach established
Change control system in place for changes to critical processes
Appropriate corrective and preventive actions (CAPA) are taken to correct deviations and prevent them
System for Management Review in place
Personnel
Organisational structure of the distributor is defined in an organisational chart. The responsibility, role and interrelationships of all personnel is clearly indicated
Responsibilities and roles of employees working in key positions is defined in written job descriptions, incl. deputyship arrangements
All personnel involved in wholesale distribution activities is qualified in GDP requirements
Training includes aspects of product identification and avoidance of falsified medicines entering the supply chain
Specific training is provided where indicated (e.g. handling of hazardous products, radioactive materials as well as products presenting special risks of abuse, narcotics or psychotropic substances, or temperature sensitive products)
Personnel receives initial and continuing training relevant to their tasks, based on written standard operating procedures (SOPs) according to a written training programme
The practical effectiveness of training is periodically assessed and documented
Responsible Person (RP) appointed
Written job description for RP in place
The qualifications of the RP meet the conditions provided by the legislation of the Member State concerned
Responsible Person fulfils relevant obligations
Premises and Equipment
Outsourcing activities
A contract is in place where premises are not directly operated by the wholesale distributor and the premises are covered by a wholesale distribution authorisation
Layout of premises:
Unauthorised access to all areas of the authorised premises is prevented
Receiving and dispatch bays protect products from prevailing weather conditions
Segregated areas are designated for the storage of any product suspected of falsification, returned product, rejected product, product awaiting disposal, recalled product and medicinal products not intended for the EU market
Radioactive materials other hazardous products and products presenting special risks of fire or explosion are stored in a dedicated area(s) with appropriate safety and security measures
There is adequate separation between the receipt and dispatch areas and storage areas
Rest, wash and refreshment rooms for employees are adequately separated from the storage areas
Hygiene
Procedures relating to personnel hygiene like health, hygiene and clothing are established and observed
Storage of food, drink, smoking materials or medication for personal use in the storage areas is prohibited
Cleaning instructions and records are in place
Premises and storage facilities are clean and free from litter and dust
Facilities are designed and equipped so as to afford protection against the entry of insects, rodents or other animals.
A preventive pest control programme is in place
Temperature and Environment Control
Suitable equipment and procedures are in place to ensure adequate control of the environment
Storage areas are temperature mapped
Temperature monitoring equipment is located according to the results of the mapping exercise
Controls are adequate to maintain all parts of the relevant storage area within defined temperature, humidity or light parameters
Equipment used to control or to monitor the environment, are calibrated and their correct operation and suitability is verified at defined intervals by the appropriate methodology
Appropriate alarm systems are in place to provide alerts when there are deviations from pre- defined storage conditions
Alarm levels are appropriately set
Alarms are regularly tested
Equipment
Planned preventive maintenance is in place for key equipment
Calibration of equipment is traceable to a primary standard
Adequate records of repair, maintenance and calibration activities for key equipment is made and the results are retained
Extent of validation and qualification activities are determined by a documented risk assessment approach and are documented in a plan
Systems are validated/qualified prior to implementation and after any significant changes or upgrades to ensure correct installation and operation
Evidence of satisfactory validation/qualification and acceptance of a process or piece of equipment is produced and approved by appropriate personnel
Re-qualification following repair or maintenance is considered dependant on the scope of the changes made. Such decisions are justified utilising a risk based approach.
Computer Systems
Detailed written descriptions of the systems are available (describing the principles, objectives, security measures and scope of the system and the main features, how the computerised system is used and the way it interacts with other systems)
Data is entered into the computerised system or amended only by persons authorised to do so
Data is secured by physical or electronic means against wilful or accidental damage
Data is protected by backing up at regular intervals
Back up data is stored for a period stated in national legislation but at least 5 years at a separate, secure location
Documentation
Documents are retained for a period stated in national legislation but at least 5 years at a separate, secure location
SOPs
SOPs are reviewed regularly and kept up-to-date
SOPs are approved, signed and dated by appropriate authorised persons
Version control is applied to SOPs
Superseded SOP versions are archived
Inadvertent use of the superseded versions is prevented
Superseded or obsolete SOPs are removed from workstations
Records
For any transaction in medicinal products received, supplied or brokered, records are kept either in the form of purchase/sales invoices, delivery slips, or on computer or in any other form
Records include the following information:
o Date
o name of the medicinal product
o quantity received, supplied or brokered
o name and address of the supplier, broker or consignee, as appropriate
o batch number where required
Distribution records contain sufficient information on distributors and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batches and quantities delivered), including those for exported products and medicinal product samples
Operations
All medicinal products distributed in the have a marketing authorisation granted by the EU or by a Member State
For distributors, not being the marketing authorisation holder: the marketing authorisation holder and the competent authority in the Member State - to which the medicinal product is imported of his intention - is notified of importation
For products being exported: a wholesale distribution authorisation or a manufacturing authorisation is in place. This is also the case if the exporting wholesale distributor is operation from a free zone.
Supplier Qualification
All supplies of medicinal products are obtained only from persons/organisations who are in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question
When medicinal product is obtained from another wholesale distributor: compliance with the principles and guidelines of good distribution practices of the supplying wholesale distributor is verified
When medicinal product is obtained from manufacturer or importer: manufacturer or importer holds a manufacturing authorisation
When medicinal product is obtained from a broker: broker is registered and complies with the requirements in Chapter 10 of the Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use
The purchase of medicinal products is controlled by written procedures
The supply chain of medicinal products is known and documented
Appropriate qualification is performed prior to any procurement
Qualification and approval of suppliers is controlled by a standard operating procedure
The results of qualification and approval of suppliers are documented
The results of qualification and approval of suppliers are periodically rechecked
Qualification and approval of new suppliers: A risk based approach is used considering
o searches for the new supplier’s reputation or reliability and its authorised activities
o possible target of falsification
o large offers of medicinal product which are generally only available in limited quantities
o out of range prices
Qualification of Customers
Medicinal products are only supplied to persons/organisations who are themselves in possession of a distribution authorisation or who are authorized or entitled to supply medicinal products to the public
Qualification of customers and periodic re-checks include:
o requesting copies of customer's authorisations
o verifying status on an authority website
o requesting evidence of qualifications or entitlement according to national legislation.
Qualification of customers are appropriately documented
Receipt of Goods
When receiving medicinal products from third countries for the purpose of importation: manufacturing/import authorisation is in place
It is ensured that that the arriving consignment is correct, the medicinal products originate from approved suppliers and have not been damaged or altered during transportation
Medicinal products which require special storage or security measures, are transferred to appropriate storage facilities immediately after appropriate checks have been conducted
In the event of any suspicion of falsified medicinal product, the batch is immediately segregated
In the event of any suspicion of falsified medicinal product, the batch is immediately reported to the national competent authority
In the event of any suspicion of falsified medicinal product, the batch is immediately reported to the marketing authorisation holder (where applicable)
Batches of medicinal products intended for the Union market are only transferred to saleable stock before assurance has been obtained that they are authorised and released for sale for the market in question
Incoming containers of medicinal products are cleaned, if necessary, before storage
Storage
Medicinal products are stored separately from other products
Medicinal products are protected from harmful effects of light, temperature, moisture or other external factors.
Particular attention is paid to products where specific storage conditions are required
Stock rotation according to the expiry dates of batches of medicinal products is performed ("first expired first out" –FEFO- basis.)
Medicinal products beyond their expiry date or shelf life are withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation
Physical removal of unsuitable stock is performed regularly
Medicinal products are not stored directly on the floor
Stock inventories are performed regularly (timings are defined using a risk based approach)
Inventory irregularities are investigated and documented
Segregation of Goods
Segregation is provided for the storage of rejected, expired, recalled or returned products and suspected falsified medicinal products
Any system replacing physical segregation such as electronic segregation based on a computerised system provides equivalent security and is validated
Destruction of obsolete Goods
Medicinal products intended to be destroyed are kept separately and handled in accordance with a written procedure.
Destruction of medicinal products is in accordance with national or international requirements for disposal of such products
Records of all destroyed medicinal products are maintained
Picking and packing
Controls are in place to ensure the correct product is picked
Products have an appropriate remaining shelf life when picked
Products are picked on a "first expired first out" (FEFO) basis
Packing is adequate to maintain the storage conditions of the product during transport
Export (exceptions)
The rules for wholesale distribution apply in their entirety in the case of export of medicinal products, with the following exceptions:
a. The medicinal product does not have to be covered by a marketing authorisation of the EU or a Member State;
b. The customer does not have to be holder of a distribution authorisation;
c. Moreover, where the medicinal product intended for exportation has been obtained directly from another third country, without the product being prior to that placed on the market (ie without prior import), the supplier does not have to bear a wholesale distribution authorisation.
Complaints, Returns & Recalls
Complaints
A written procedure is in place for the handling of complaints
Distinction is made between complaints about the quality of a medicinal product and those relating to distribution
A person is appointed for handling the complaints with sufficient supporting personnel
Any complaint concerning a potential product defect or a potential falsified product is recorded with all the original details and investigated
The national competent authority is notified without delay in case of a potential product defect or a potential falsified product
Any product distribution complaint is thoroughly investigated
Appropriate follow-up actions are taken after investigation and evaluation of the complaint
Returned Medicinal Products
Written procedures are in place for the handling and acceptance of returned medicinal products
Medicinal products which have left the premises of the distributor are only returned to saleable stock if:
o the medicinal products are in their unopened and undamaged secondary packaging and in good condition
o medicinal products returns from a customer not holding a wholesale distribution are returned within five days of original dispatch;
o it is demonstrated that the medicinal products have been transported, stored and handled under proper specified/predefined conditions;
o they have been examined and assessed by a sufficiently trained and competent person authorised to do so;
o the distributor has reasonable evidence that the product was supplied to that customer
o the batch number of the dispatched product is known
o a copy of the original delivery note is attached
o there is no reason to believe that the product has been falsified
o there is evidence that the product has been stored within the authorised storage conditions throughout the entire time
A risk assessment is performed taking into account the product concerned, any specific storage requirements and the time elapsed since the medicinal product was originally dispatched
Returned medicinal products are kept segregated from saleable stock until a decision is taken regarding their disposition
Products returned to saleable stock are placed that the "first expired first out" (FEFO) system operates effectively
All handling of returned medicinal products including their return to saleable stock or disposal are approved by the Responsible Person and recorded
Suspected falsified Medicinal Products
The staff is aware of the risks of falsified medicinal products entering the supply chain
A procedure is in place describing immediate information of the competent authority and, where applicable, the marketing authorisation holder of the medicinal products they identify as falsified or suspect to be falsified
Any suspected falsified medicinal products found in the supply chain is immediately physically and securely segregated from legitimate medicinal products
All relevant activities are recorded
Medicinal Product Recalls
There is a written procedure for the management of recalls
The management of recalls and its effectiveness is periodically tested and evaluated (Mock Recall)
Any recall operation is recorded at the time it is carried out
The distribution records are readily available to the person(s) responsible for the recall
The progress of a recall process is recorded and a final report issued (including reconciliation between the delivered and recovered quantities of the medicinal products)
Transportation
Vehicles and equipment
Required storage conditions are maintained during transportation
Vehicles and equipment are suitable and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity, and to prevent contamination of any kind
Procedures are in place for the operation and maintenance of all vehicles and equipment, including cleaning and safety precautions
Validated temperature-control systems (e.g. thermal packaging, temperature-controlled containers, and refrigerated vehicles) are used to ensure correct transport conditions
If refrigerated vehicles are used temperature mapping is performed under representative conditions including seasonal variations
Equipment used for temperature monitoring during transport within vehicles and/or containers, is maintained and calibrated at regular intervals at least once a year
If cool-packs are used in insulated boxes, they are located such that the product does not come in direct contact with the cool-pack
If cool-packs are used in insulated boxes, staff is trained on the procedures for assembly of the insulated boxes (seasonal configurations) and on the reuse of cool-packs.
The process for delivery of sensitive products and control of seasonal temperature variations is described in written procedures
Procedures cover management of unexpected occurrences such as vehicle breakdown or non- delivery.
A procedure is in place for investigating and handling temperature excursions
Where non-dedicated vehicles and equipment are used procedures are in place to ensure that the quality of the medicinal product will not be compromised
Delivery
Delivery drivers (including contract drivers) are trained in the relevant areas of GDP
Deliveries are made directly to the address stated on the delivery note
Deliveries are handed into the care of the consignee.
Deliveries are not left on alternative premises
Transportation hubs
When using transportation hubs, has the maximum time limit for storage in these locations been defined
When using transportation hubs, premises are audited and approved prior to deployment
is there a specification for transport hubs
is there a list of Hubs used by the transportation company?
Deviations
Deviations are reported to the distributor and recipient
Where necessary in the case of deviations, the manufacturer of the medicinal product is contacted for information about appropriate steps to be taken
Containers, packaging and labelling
Container and packaging is selected based on:
o the storage and transportation requirements
o the space required for the amount of medicines
o the anticipated external temperature extremes
o the estimated maximum time for transportation including transit storage at customs
o the validation status of the packaging and shipment containers
The containers in which medicinal products are shipped are sealed
A document is enclosed to ascertain the following:
o Date
o name and pharmaceutical form of the medicinal product
o batch number at least for products bearing the safety features, where required
o quantity supplied
o name and address of the supplier
o name and delivery address of the consignee (actual physical storage premises, if different)
o applicable transport and storage conditions
Containers bear labels providing sufficient information on handling and storage requirements and precautions
Containers bear labels enable identification
Transportation of Products requiring special Conditions
Requirements laid down by the concerned Member States are met
Additional control systems in place
Transportation is performed in safe, dedicated and secure containers and vehicles
Completion
Final observations recommendations
Sign off
This template was downloaded 68 times
This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.