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Auditing of vendors and production department

Auditing of vendors and production department

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Chp: 03
“ Auditing of Vendors and ProductionDepartment”
 Vendor Audit
The primary areas that need to be evaluated in a vendor audit are vendor viability,
management responsibility and system accuracy.
The main objectives for a vendor audit are to assess the quality management of the
whole organization, through its procedures and data processes.
It is an assessment of quality controlmeasures taken by the vendor to assure that
their products and services are acceptable for business transaction.
The audit is performed by the representative of purchase department i.e.QA
department.
Some of the important parameters taken into consideration while auditing:
Vendor Audit- Pharmaceuticals
• ISO Certifications
• USFDA
• Documented Quality Policy
• Packaging and Labeling Standards
PRESENTD BY :-
PATIL PRANJAY SADASHIV.
FIRST YEAR M.PHARM.
DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education and Research,
Shirpur
Auditing of Vendors and Production Department
2
• Premises and manufacturing facilities
Vendor audits in the pharmaceutical industry may be perceived to be a burden for
some vendors and a resource drain for the pharmaceutical companies, they are
valuable and necessary processesmeant to benefit both. This is especially so when
dealing with life-saving medications.
An audit is a method used by not only pharmaceutical companies but most large
companies as well. The goal is to inspect and evaluate a vendor’s quality
management system (QMS), as well as its overriding practices, producthandling
and data integrity of all relevant documentation.
In an industry required to be more regulated than any other industry in the world,
quality and adherence to predetermined standards is not an option. Lives depend on
it.
There are specific areas of compliance that are reviewed:
• Is the vendor equipped to meet all required standards?
• Is the senior management of the vendor company responsible and committed to
the standards required?
• Are the vendor systems accurate, well maintained and do the audit results meet
all criteria?
• Is the vendors’ data handling above the standards?
The goal of any vendor audit is to assess the quality management of the entire
organization, through its procedures and processes.
Quality controlis assessed based on the efforts taken by the vendor to ensure their
products and services meet all needs to conductbusiness and process transactions.
As well, all computer systems that are used by the vendor to conductbusiness will
be assessed and tested.
Need of Conducting a Vendor Audit
1. In order to reduce the cost.
2. Though it has drastically reduced the production costfor companies, there is a
heightened supplier risk and lack of visibility into supplier processes.
3
3. To gain an insight into supplier processesand eliminate the risks, FDA
encourages companies to conductGMP supplier audit at the manufacturing
premises of the supplier.
4. According to PIC/S GMP code, it is your sole responsibility to ensure that the
supplier’s manufacturing processes, analytical tests and examinations are carried
out reliably by the supplier and are in compliance with the applicable standards
and regulations.
5. After the audit, supplier must provide an appropriate corrective action plan with
measures that will be implemented by the supplier within a defined timeframe to
the manufacturer.
Steps-by-Step Guide to Supplier Audit
Supplier auditing is a necessary part of quality management system.
Before signing a deal with a new supplier, a thorough supplier audit is conducted
to ensure that the supplier always delivers high quality and standard products.
Following are the steps to successfully perform the supplier audit.
1. Schedule a time for audit by contacting the supplier.
2. Prepare the outline of the audit plan and review the vendor’s performance
history.
3. Conductthe audit as scheduled, at the same time keep the supplier’s schedule in
mind. Their activities shouldn’t be hindered. Take a note of how the supplier’s
team welcomes and greets you because this reflects the ethics and principles of
the vendor.
4. Take an inspection tour to the manufacturing premises, have a close look at the
equipments and safety issues.
5. Check the supplier’s invoices to know if they are charging you accurately.
There should be no inconsistencies in unexplained miscellaneous charges, shipping
and transportation fees.
4
Keep taking notes throughout the process.It will help you when writing evaluation
report and addressing the issues.
Supplier Selection
The purposeof this step is to define a set of criteria that can be taken into
consideration in the selection process ofa supplier.
The supplier selection process starts with the definition of the user requirements for
the materials(s) within scope.
The user requirement specifications provided to purchasing should contain as a
minimum the following information:
• Name of the product
• Material specifications
• Quantity required
The materials within scopeof this guidance have been classified as follows:
• Non-critical raw materials
• Critical raw materials
• Registered intermediates
• APIs
Procedure for inclusion of vendor in approved vendor list (Raw
materials)
New vendors must be qualified and approved by QA department before regular
supply of raw materials in following manner.
1. Purchase department will locate the new vendor and find out the details of
products manufactured / supplied by them. In case of existing materials,
Purchase department will provide our specification to the new vendor.
2. Purchase department will submit the samples to QA department or R&D
department for evaluation as per specifications.
3. Samples from 3 consecutive lots / batches of active ingredient should be
procured as pre-shipment sample along with certificate of analysis. Foractive
5
as well as excipients, Assurance / Declaration of compliance with TSE / BSE
requirement or material is of vegetable origin shall be taken from the
manufacturer.
4. Quality Assurance or R&D department should analyze the sample.
5. After complete analysis of the sample, the analytical report along with the
comments of QA department shall be sent to Purchase department. The vendor
will be included in the temporary approved vendor list if the samples are
meeting the specifications. The new addition to the list are entered manually
and approved by Head QA & QC till the list is amended.
6. Purchase department after studying the comments of QA department shall
inform the supplier for the supply of the material manufactured by them.
7. An audit is performed by representative of Purchase department, QA
department.
a) Active Raw Material / Excipients vendor audit report shall be prepared.
b) A supplier questionnaire is sent to suppliers.
c) However the visit and audit of vendor shall not be considered as an approving
criteria and based on the previous history, background and quality trial lots
supplied by the supplier, the vendor may be included in approved vendor list.
8. Purchase department shall carefully study the quality aspect and also the
quantity and financial aspects ofthe vendor, they are as follows;
a) Capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the productioncycle.
c) The rates quoted by the vendor whether they are competitive with respect to
other vendors without compromising the quality aspects.
9. Based on the productcompliance and assessment, further procurement of
active raw material should be continued. On ensuring compliance with
specifications the vendor shall be included in permanent vendor’s list during
update of list.
10. All the suppliers evaluated by R&D department on the basis of process /
productdevelopment parameters shall be considered as temporary vendors and
will be included in temporary approved vendor list.
6
Based on the commercial productionsupply, they will be transferred to approved
vendor list and shall be considered as permanent approved vendors.
11. Vendors recommended by R&D having drug master file number shall be
included as temporary vendors and based on the performance on commercial
supply for production batches, will be transferred to approved vendor list.
12. Vendors approved by the productlicense holder or contract giver will be
listed separately as approved for productlicense holder products.
Procedure for inclusion of vendor in approved vendor list
(Packaging material)
New vendors must be qualified and approved by QA department before regular
supply of packaging materials in following manner.
1. Purchase department will locate the new vendor and find out the details of
products manufactured / supplied by them. In case of existing materials, Purchase
department will provide our specification to the new vendor.
2. For printed and primary packaging materials, vendor audit is performed by
representative of Purchase department, QA department.
3. Samples of printed packaging materials if necessary will be submitted to QA
department for evaluation.
4. Purchase department after studying the comments of QA department shall
inform the supplier for the supply of the material manufactured by them.
5. Purchase department shall carefully study the quality aspectand also the
quantity and financial aspects ofthe vendor, they are as follows;
a) Capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the productioncycle.
c) The rates quoted by the vendor whether they are competitive with respect to
other vendors without compromising the quality aspects.
6. Based on the productcompliance and assessment, further procurement of
packaging material should be continued. On ensuring compliance with
specifications the vendor shall be included in permanent vendor’s list during
update of list.

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Auditing of vendors and production department

  • 1. 1 Chp: 03 “ Auditing of Vendors and ProductionDepartment”  Vendor Audit The primary areas that need to be evaluated in a vendor audit are vendor viability, management responsibility and system accuracy. The main objectives for a vendor audit are to assess the quality management of the whole organization, through its procedures and data processes. It is an assessment of quality controlmeasures taken by the vendor to assure that their products and services are acceptable for business transaction. The audit is performed by the representative of purchase department i.e.QA department. Some of the important parameters taken into consideration while auditing: Vendor Audit- Pharmaceuticals • ISO Certifications • USFDA • Documented Quality Policy • Packaging and Labeling Standards PRESENTD BY :- PATIL PRANJAY SADASHIV. FIRST YEAR M.PHARM. DEPARTMENT OF QUALITY ASSURANCE. H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur Auditing of Vendors and Production Department
  • 2. 2 • Premises and manufacturing facilities Vendor audits in the pharmaceutical industry may be perceived to be a burden for some vendors and a resource drain for the pharmaceutical companies, they are valuable and necessary processesmeant to benefit both. This is especially so when dealing with life-saving medications. An audit is a method used by not only pharmaceutical companies but most large companies as well. The goal is to inspect and evaluate a vendor’s quality management system (QMS), as well as its overriding practices, producthandling and data integrity of all relevant documentation. In an industry required to be more regulated than any other industry in the world, quality and adherence to predetermined standards is not an option. Lives depend on it. There are specific areas of compliance that are reviewed: • Is the vendor equipped to meet all required standards? • Is the senior management of the vendor company responsible and committed to the standards required? • Are the vendor systems accurate, well maintained and do the audit results meet all criteria? • Is the vendors’ data handling above the standards? The goal of any vendor audit is to assess the quality management of the entire organization, through its procedures and processes. Quality controlis assessed based on the efforts taken by the vendor to ensure their products and services meet all needs to conductbusiness and process transactions. As well, all computer systems that are used by the vendor to conductbusiness will be assessed and tested. Need of Conducting a Vendor Audit 1. In order to reduce the cost. 2. Though it has drastically reduced the production costfor companies, there is a heightened supplier risk and lack of visibility into supplier processes.
  • 3. 3 3. To gain an insight into supplier processesand eliminate the risks, FDA encourages companies to conductGMP supplier audit at the manufacturing premises of the supplier. 4. According to PIC/S GMP code, it is your sole responsibility to ensure that the supplier’s manufacturing processes, analytical tests and examinations are carried out reliably by the supplier and are in compliance with the applicable standards and regulations. 5. After the audit, supplier must provide an appropriate corrective action plan with measures that will be implemented by the supplier within a defined timeframe to the manufacturer. Steps-by-Step Guide to Supplier Audit Supplier auditing is a necessary part of quality management system. Before signing a deal with a new supplier, a thorough supplier audit is conducted to ensure that the supplier always delivers high quality and standard products. Following are the steps to successfully perform the supplier audit. 1. Schedule a time for audit by contacting the supplier. 2. Prepare the outline of the audit plan and review the vendor’s performance history. 3. Conductthe audit as scheduled, at the same time keep the supplier’s schedule in mind. Their activities shouldn’t be hindered. Take a note of how the supplier’s team welcomes and greets you because this reflects the ethics and principles of the vendor. 4. Take an inspection tour to the manufacturing premises, have a close look at the equipments and safety issues. 5. Check the supplier’s invoices to know if they are charging you accurately. There should be no inconsistencies in unexplained miscellaneous charges, shipping and transportation fees.
  • 4. 4 Keep taking notes throughout the process.It will help you when writing evaluation report and addressing the issues. Supplier Selection The purposeof this step is to define a set of criteria that can be taken into consideration in the selection process ofa supplier. The supplier selection process starts with the definition of the user requirements for the materials(s) within scope. The user requirement specifications provided to purchasing should contain as a minimum the following information: • Name of the product • Material specifications • Quantity required The materials within scopeof this guidance have been classified as follows: • Non-critical raw materials • Critical raw materials • Registered intermediates • APIs Procedure for inclusion of vendor in approved vendor list (Raw materials) New vendors must be qualified and approved by QA department before regular supply of raw materials in following manner. 1. Purchase department will locate the new vendor and find out the details of products manufactured / supplied by them. In case of existing materials, Purchase department will provide our specification to the new vendor. 2. Purchase department will submit the samples to QA department or R&D department for evaluation as per specifications. 3. Samples from 3 consecutive lots / batches of active ingredient should be procured as pre-shipment sample along with certificate of analysis. Foractive
  • 5. 5 as well as excipients, Assurance / Declaration of compliance with TSE / BSE requirement or material is of vegetable origin shall be taken from the manufacturer. 4. Quality Assurance or R&D department should analyze the sample. 5. After complete analysis of the sample, the analytical report along with the comments of QA department shall be sent to Purchase department. The vendor will be included in the temporary approved vendor list if the samples are meeting the specifications. The new addition to the list are entered manually and approved by Head QA & QC till the list is amended. 6. Purchase department after studying the comments of QA department shall inform the supplier for the supply of the material manufactured by them. 7. An audit is performed by representative of Purchase department, QA department. a) Active Raw Material / Excipients vendor audit report shall be prepared. b) A supplier questionnaire is sent to suppliers. c) However the visit and audit of vendor shall not be considered as an approving criteria and based on the previous history, background and quality trial lots supplied by the supplier, the vendor may be included in approved vendor list. 8. Purchase department shall carefully study the quality aspect and also the quantity and financial aspects ofthe vendor, they are as follows; a) Capability of the vendor to supply the required material within the period. b) Delivery schedule in order not to affect the productioncycle. c) The rates quoted by the vendor whether they are competitive with respect to other vendors without compromising the quality aspects. 9. Based on the productcompliance and assessment, further procurement of active raw material should be continued. On ensuring compliance with specifications the vendor shall be included in permanent vendor’s list during update of list. 10. All the suppliers evaluated by R&D department on the basis of process / productdevelopment parameters shall be considered as temporary vendors and will be included in temporary approved vendor list.
  • 6. 6 Based on the commercial productionsupply, they will be transferred to approved vendor list and shall be considered as permanent approved vendors. 11. Vendors recommended by R&D having drug master file number shall be included as temporary vendors and based on the performance on commercial supply for production batches, will be transferred to approved vendor list. 12. Vendors approved by the productlicense holder or contract giver will be listed separately as approved for productlicense holder products. Procedure for inclusion of vendor in approved vendor list (Packaging material) New vendors must be qualified and approved by QA department before regular supply of packaging materials in following manner. 1. Purchase department will locate the new vendor and find out the details of products manufactured / supplied by them. In case of existing materials, Purchase department will provide our specification to the new vendor. 2. For printed and primary packaging materials, vendor audit is performed by representative of Purchase department, QA department. 3. Samples of printed packaging materials if necessary will be submitted to QA department for evaluation. 4. Purchase department after studying the comments of QA department shall inform the supplier for the supply of the material manufactured by them. 5. Purchase department shall carefully study the quality aspectand also the quantity and financial aspects ofthe vendor, they are as follows; a) Capability of the vendor to supply the required material within the period. b) Delivery schedule in order not to affect the productioncycle. c) The rates quoted by the vendor whether they are competitive with respect to other vendors without compromising the quality aspects. 6. Based on the productcompliance and assessment, further procurement of packaging material should be continued. On ensuring compliance with specifications the vendor shall be included in permanent vendor’s list during update of list.
  • 7. 7 7. All the suppliers evaluated by R&D department on the basis of process / productdevelopment parameters shall be considered as temporary vendors and will be included in temporary approved vendor list. Based on the commercial production supply, they will be transferred to approved vendor list and shall be considered as permanent approved vendors. Procedure for exclusion of vendor from approved vendor list 1. The vendor shall be disqualified and removed from the approved vendor’s list for the following reasons: a) If a lot does not comply to the specification with respect to critical tests then the vendor shall be disqualified. The vendor shall be qualified again on further evaluation and investigation. b) If a lot does not comply to the specification with respect to minor tests then the vendor shall be disqualified if it is observed for 3 consecutive lots. c) 3 out of 10 lots fail to comply the specification in a specified period under review. d) The delivery schedule is not met for 40% supplies. 2. The rates mentioned in Purchase Order, differs than the rates mentioned in delivery challan and invoice. Corrective and preventive action The vendor, who has been excluded from the approved vendor’s list, may be included again by taking following corrective and preventive actions; 1. The vendor shall be made aware of the reasons for his exclusion and shall be asked to explain. 2. Head Purchase and Head QA&QC shall conductfacility audit of the vendor in order to ensure that quality system exists in the organization. 3. Carry out the discussion on other non-quality issues like delivery schedule and rate, etc. 4. After satisfactory compliance of all above points, the vendor shall be included in Temporary Vendor List.
  • 8. 8 Vendor Evaluation Supplier Evaluation and audits can be considered as an integral part of assessment in any kind of industry or organization. As the entire industry chore depends on the type of materials supplied for the production as these raw materials will only shape up into the actual end productor the final product. So, it becomes very essential to ensure that the persons that supply the raw materials in an industry are of good quality and standard and the materials they supply comply with all the industry set standards and policies. The evaluation is a term used in a business scenario which refers to the process of evaluating and approving potential suppliers by accurate and measurable assessments. The purposeof this evaluation is to ensure that an industry has tied up with a first class company that are both reliable and efficient and offer 100% genuine and quality products. The quality system evaluation may be less or more elaborate in function of the identified material classes and follows a documented process. The following information from the supplier should be requested as part of the Suppliers Questionnaire. • Specifications • Manufacturing/packaging/labeling details • MSDS • Logistic information (lead time to produce, delivery time, etc) Analytical test method It is a pre-requisite to demonstrate that the material provided by the potential supplier meets the specification as defined and compliance to the specifications should be verified by analytical testing of a sample. Hence, checking and evaluating the quality of the providers can take much of strength and time as they may reside at the far end. So a propersolution for this can be through Supplier Audits.
  • 9. 9 Supplier Audits are one of the best ways to ensure that supplier is following the processes and procedures that you first agreed upon during the initial selection process. The audit helps in identifying all the non conformances associated with the manufacturing process,shipment process and quality process ofEvaluation. Once the audit is completed, the provider and the manufacturer identify all the needed actions that have to be implemented in order to bring about a corrective change within a scheduled time. Auditing Packaging Material Vendors Goals When you have completed this unit, you should be able to: · Perform a packaging component supplier audit. Understand which worldwide requirements apply to packaging component suppliers. Use a range of information tools, including the contents of this module, in support of a packaging componentsupplier audit. · Recognize compliance or non-compliance with regulations pertaining to packaging component supplier’s requirements. Gang-printed labeling: Labeling derived from a sheet of material on which more than one item of labeling is printed. (see example below). Gang printing is considered to be an unacceptable practice for some industry since it increases the potential for label mix-up. Packaging materials:Any material employed in the packaging of a medicinal product, excluding any other packaging used for transportation or shipment. Packaging Component – Critical (PCC): Is any printed packaging component, primary (productcontact) component or device. Furthermore any secondarypackaging component critical to the microbiological integrity, stability and/or administration of the product(e.g. Aluminum pillow packs around semi permeable). Packaging Component – Non-Critical(PCNC): Is any non-printed or secondary(non contact) packaging componentor device that does not fall within the definition of a PCC.
  • 10. 10 Printed packaging components:Packaging materials that are printed and/or otherwise decorated. Examples would include cartons, labels, leaflets. Reconciliation:A documented comparison between the amount of input materials and the output product, taking into account waste, samples and other losses inherent in the process Auditing Packaging Material Vendors Line clearance Line clearance is an essential element in productmix up prevention and needs to focus on: • Input materials on the line from the previous batch • Samples and waste from the previous batch • Documents on the line from the previous batch • Verification that any electronic data is wiped from consoles etc. • Clearance after maintenance activity or major interruptions as appropriate. • Line clearance activities need to be documented and cover all areas, not just the machine or line • The whole machine, including hoppers, conveyers, reject stations, etc • Benches, cupboards, shelves around the line • The line clearance should be documented, signed and an independent check completed and signed before the area is released for use. Contamination control: The facilities should be designed and laid out to appropriately reduce the risk of contamination from the environment and permit effective cleaning. Personnel gowning and hygiene practices are part of contamination controlefforts that may be applicable. The supplier should define the appropriate environmental conditions for handling and storage of the component(s)being manufactured. Guidance for minimum conditions can be found in PS 9000 Pharmaceutical Packaging Materials, as well as programs such as ISO 9001:2000 and ISO 9004:2000 for pharmaceutical packaging materials. Validation and Qualification Ensure the processes are adequately validated, qualified and/or demonstrated according to the quality critical parameters of the component being manufactured. This may be demonstrated in the form of capability studies.
  • 11. 11 Sampling There should be an SOP that defines package component sampling. The components sampled should be representative of the batch and sampling should be conducted to prevent contamination from the sampling method. Any packaging materials that meet appropriate written specifications should be formally approved and released for use. Any components that fail to meet such specifications must be rejected to prevent distribution. Samples taken away from the line should not be returned to the line. They should be reconciled and placed in dedicated containers for destruction. Documentation The appropriate SOPs and batch records must be followed when documenting any information or data associated with a component manufacture. Other pertinent types of documentation include: · Records ofhow and who set up a particular machine. Brokendown to its fundamental components, an injection machine is comprised of 3 functional units: 1. Injection – which melts and transmits the plastic granules? 2. Mold – the design portion which produces a specialized product 3. Clamping – which provides the controlled pressureto open and close the mold. Injection blow molding is normally used for high quality bottles. Compared to extrusion blow molding, injection molding gives better definition of details and better control of thickness of the material. Important quality considerations are • Traceability of the polymer is maintained, that only virgin polymer is used (not regrind polymer). • Key manufacturing parameters such as Temperature and Pressure ß Testing of polymer, for example, Melt Flow Index • Maintenance and cleaning of the molds, cavities and barrel. • Controls and confirmation of the critical specifications during manufacturing. For example, thickness of walls confirmed through QC inspection as a part of in process testing.
  • 12. 12 There are many manufacturers of syringes, and while each one uses a slightly different process, the basic steps remain the same: 1. Needle formation 2. Plastic component molding 3. Piece assembly, 4. Packaging, 5. Labeling and 6. Shipment The needle is normally produced from steel, which is heated and drawn through a die design to meet the size requirements. Most needles are purchased from specialist manufacturers. The syringe tube can be manufactured by injection molding or glass manufacture as required. When all of the component pieces are available, final assembly can occur. As the tubes travel down the conveyer, the ends that cap the tube are affixed. Graduation marks are applied as appropriate, and the needle and safety cap can be attached at this time. Manufacture should be in a clean environment and final componentfree from contamination. The quality components used to manufacture syringes should be checked during each phase of the manufacture. Components should be checked to ensure size; shape and consistency are within specifications. Measuring equipment with the defined accuracy and precision should be used for measurement of the components. Forces to activate the plunger dismantle the syringe, removal of cap and removal of needle should be tested, reported and controlled. The reporting of quality attributes during manufacture is often completed on Statistical Control Charts where the manufacturing process caneasily be monitored. Key Parameters of a Packaging Component Audit Prior to the audit · Develop an understanding of the vendor manufacturing process specific to company requirements • Obtain a list of company components that are manufactured at the site. • Review recent rejections, complaints and issues, of the receiving site(s) and the respective statuses. • Review any Quality Agreements and relevant registration requirements.
  • 13. 13 • Review compliance status of the site by checking for service history, recalls associated with the site, recent regulatory inspections (if applicable) and outcomes. • Review previous audit reports and actions. During the audit • Perform a walkthrough of the manufacturing area. • Ensure the production areas are clean and tidy. • Ensure the fabric is in good condition and appropriate design for control of the process Warehousing Objective Factory stores will invariably be receiving duly approved raw materials and packaging materials from third party. - A suitable spaceis provided to raw material and packaging materials for each contract manufacturer. This spaceis known as Warehouse. A pharmaceutical warehouse To enable the fastest and cheapest transport of drugs and medical equipment from suppliers to beneficiaries. There are mainly 3 stages: (1) Purchase of pharmaceutical products (2) Storage of ordered products (3) Distribution of stocked products Premises Principle: Premises must be locked, designed, constructed, adapted, and maintained to suit the operations to be carried out. Storage condition • Temperature - Daily monitoring and recorded every house. - Temp. in warehouse must not exceed 25-30oC.
  • 14. 14 • Air - All containers should be hermetically closed. - Avoid prolonged unpack age material. - Premises should be ventilated. • Light - Many API should be stored in dark room. - API should not be directly exposed to sunlight and not to be issued until and unless it is required in manufacturing. Shelf life of the product  Expiry Date - It must appear on the package and/or on the product. - The expiration date applies to a drug in its original closed and undamaged package or container.  Management of outdated products - First, the expired products must be removed from the stock of the products. Stored in a locked area. - Secondly, these products are stored by form to be destroyed in compliance with law and regulations. General requirement for warehousing Clean the premises with disinfectants.  To clean the ground surface regularly.  To clean the undergrowth from around the warehouse regularly.  Smoking and eating must be forbidden in the premises.  Facility of locking doors and protective windows.  To provide extinguishers to fight fires.  To fight against pests.  Adapted and functional lighting as well as generators ready to works. Stock management Objectives  To ensure continuity of supplies  To avoid over stocking –Stockmanagement will set out to;  Monitor stocklevels  Monitor consumption  Anticipate delivery time for order activation
  • 15. 15 Documentation Stock cardDefinition It is a simple and efficient tool that enables the management of a warehouse. A stockcard should be created for each pharmaceutical productand regularly updated. They must be easily accessible. It is necessary to  Identify stockmovement: incoming and outgoing products  Know the theoretical stocklevel at any point in time  Monitor the consumption of the different users  Monitor expiry dates  Assess losses by comparing the theoretical and real stocks  Have data to plan subsequentorders. Inventories  It is essential to make an inventory of the quantities that really are in stock. Mistakes, omission or thefts can explain the differences between the theoretical and real stock. Thosedifferences should of course be cleared up.  Inventory makes it possible to check the expiry dates of all the pharmaceutical products.  Inventories should be made on a regular basis with a frequency defined by a procedurespecific to each warehouse.  On the day of the inventory, all activities should be stopped except the counting of stocks:NO IN OR OUT MOVEMENT OF PRODUCTES on that day.  The inventory should be conducted in a minimum time and the results should immediately be recorded to enable normal working to resume. Reception of goods Inspection of an order  A separate rack should be provided to store approved raw and packaging materials. Materials that are waiting for approval should be kept in
  • 16. 16 “Quarantine area”.  After receiving approval, it should be taken into stock. Quarantine materials should be labeled “Under Test” till it released by Quality control division. The warehouse staff (1) The responsible pharmacist (2) The warehouse keeper (3) The warehouse worker (4) The cleaner (5) The security guard Quality Assurance  SOPs ofeach warehouse will have to establish operating procedures.  They must be clearly defined for each stage activities.  Direct purchase from raw materials manufactures.  Purchase via Head quarters.  Reception of local and imported orders.  Unpacking, labeling and storage of products.  Computerized stock managements.  Preparations of an order for delivery.  Returns of drugs - Managements of outdated drugs.  Safety and cleanliness of premises. Audits Audits aim at assessing the activities and organization of the warehouse.  Their aim at answering key questions such likes.  Have initially set of activities & quality objectives been reached?  Are procedures correctly written respected, reviewed?  Does the warehouse guarantee for safety standards? ( Ref: https://www.pharmaguideline.com)