This presentation is prepared by “ Drug Regulations” a
non profit organization which provides free online
resource to the ...
This presentation is compiled from freely available
resources like the website of EU , EMA , specifically
“Guidelines on p...
 “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION
PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL
PRODUCTS FOR HUMAN USE”...
 Based on the fourth paragraph of Article 47 of
Directive 2001/83/EC
 Follow principles of
◦ EudraLex Volume 4, Part II,...
 Provide stand-alone guidance on Good Distribution
Practice (GDP)
 To be followed by
◦ Importers and distributors of act...
 Commission Delegated Regulation (EU) No
1252/2014 (3) and EudraLex Volume 4, Part II are
applicable to
◦ Any manufacturi...
Additional requirements apply to the importation of
active substances, as laid down in Article 46b of
Directive 2001/83/EC...
These Guidelines are applicable as of
September 21 , 2015.
3/29/2015 8
Drug Regulations - Online
Resource latest informati...
 Applicable to distribution of active substances,
◦ Defined in Article 1(3a) of Directive 2001/83/EC, for
medicinal produ...
 Active substances,
◦ An active substance is any substance or mixture of
substances intended to be used in the manufactur...
 Distribution of active substances shall comprise all
activities consisting of
◦ Procuring
◦ Importing
◦ Supplying or exp...
 Develop and maintain a quality system
 Set out responsibilities
 Use process and risk management principles
 Examples...
 Should be adequately resourced
 Competent personnel
 Suitable and sufficient premises
 Equipment and facilities
3/29/...
 Quality System should ensure that:
1. Active substances are procured, imported, held, supplied or
exported in a way that...
 Quality System should ensure that:
4. Deviations from established procedures are documented
and investigated;
5. Appropr...
 Development & Modification of Quality
System
◦ Consider the size, structure and complexity of
the distributor’s activiti...
 Designated person
◦ Appoint at each location where distribution activities
are performed
◦ Should have defined authority...
 Specify & document responsibilities of all
 Should have the appropriate competence
and experience
 Should ensure that ...
 Training
◦ Initial
◦ Continuing / ongoing
◦ Relevant to their role
◦ Based on written procedures
◦ In accordance with a ...
 Documentation
◦ Paper or in electronic data
◦ Written procedures
◦ Instructions
◦ Contracts
◦ Records
◦ Readily availabl...
 Documentation
◦ Sufficiently comprehensive w r t distributor’s
activities
◦ In a language understood by personnel
◦ Clea...
 Documentation
◦ Any alteration should be signed and dated
◦ Any alteration should permit the reading of the
original inf...
 Written
 Describe distribution activities which affect
the quality of the active substances
◦ Receipt and checking of d...
 Describe distribution activities which affect the
quality of the active substances
◦ Maintenance of the premises & Pest ...
 Procedures
◦ Approved
◦ Signed
◦ Dated
 By person responsible for the quality system
3/29/2015 25
Drug Regulations - On...
 Procedures
◦ Use only valid and approved procedures
◦ Review regularly
◦ Keep up to date
◦ Apply version control
◦ Imple...
 Records
◦ Clear
◦ Be made at the time each operation is performed
◦ Significant activities or events are traceable
◦ Ret...
 Records that should be retained and be available include:
(i) Identity of supplier, original manufacturer, shipping agen...
 Records
◦ Each purchase and sale
◦ Date of purchase or supply
◦ Name of the active substance
◦ Batch number
◦ Quantity r...
 Records
 Records that should be retained and be available include:
(i) Identity of supplier, original manufacturer, shi...
 Premises & Equipment
◦ Suitable and adequate
◦ Ensure proper storage & protection from
contamination
 Narcotics
 Highl...
 Premises & Equipment
◦ Suitably secure to prevent unauthorised
access
◦ Installed with monitoring devices to
guarantee t...
 Orders
◦ Manufacturer, importer or distributor of
API established in the EU should be
registered according to Article 52...
 Receipt
 Reception area
◦ Protect deliveries from prevailing weather
conditions during unloading
◦ Separate from the st...
 Receipt
 Examine deliveries
(i) Containers are not damaged;
(ii) All security seals are present with no sign of tamperi...
 Receipt
◦ Quarantine consignment
 Physical
 Equivalent Electronic system
◦ Broken seals
◦ Damaged packaging
◦ Suspecte...
 Receipt
◦ Specific storage measures
 Narcotics
 Products requiring a specific storage
 Temperature or humidity
◦ Iden...
 Receipt
◦ Falsified A P I
◦ Segregate
 Physically or
 Using an equivalent electronic system
◦ Inform the national comp...
 Receipt
◦ Rejected materials
◦ Identify
◦ Control
◦ Quarantined
 Prevent use in manufacturing
 Prevent further distrib...
 Storage
◦ Store under conditions specified by the manufacturer
◦ Controlled temperature and humidity when necessary
◦ In...
 Storage Facility / Area
◦ Clean
◦ Free from litter, dust and pests
◦ Implement precautions against
 Spillage
 Breakage...
 Storage
◦ Implement stock rotation,
 ‘first expiry (retest date), first out’,
◦ Check regularly that the system is oper...
 Contracted Storage & Distribution
◦ Ensure that contractor
 Knows his responsibilities
 Follows the appropriate storag...
 Deliveries to customers
◦ Supplies within the EU
 Only by distributors registered according to Article
52a of Directive...
 Deliveries to customers
◦ Transport in accordance with conditions specified by
the manufacturer
◦ Transport should not a...
 Transfer of Information
◦ Notification to customers
 Any adverse information or event
 Potential to cause an interrupt...
 Transfer of Information
◦ Regulatory Information
◦ Product Quality Information
 Distributor responsible for transfer
 ...
 Transfer of Information
◦ Distributor to provide information from the manufacturer to
the customer :
 Name and address ...
 Returns
 Identify
 Quarantine
 Conduct investigation
3/29/2015 49
Drug Regulations - Online
Resource latest informati...
 Active substances should only be returned to saleable stock
if:
 The active substance is in the original unopened conta...
 Maintain records of returns.
 Include following details in the records:
 Name and address of the consignee
 Active su...
 This assessment should take into account
 The nature of the active substance
 Any special storage conditions it requir...
 Release to active stock
◦ Only by appropriately trained and authorised
personnel
◦ Place such that the 'first expiry (re...
 Complaints
◦ May be received orally or in writing
◦ Record all complaints
◦ Investigate according to a written procedure...
 Complaints
◦ Determine need for further action
 With other customers
 With the competent authority
 Or both.
◦ Conduc...
 Complaint records should include:
◦ Name and address of complainant
◦ Name (and, where appropriate, title) and phone num...
 Retain records of complaints
 Take appropriate corrective action
 Evaluate
◦ Trends
◦ Product related frequencies
◦ Se...
 Responsibility of Original
Manufacturer
◦ Distributor may refer to Original Manufacture
◦ Distributor record should incl...
 Serious or Potentially life-threatening
situation
 Inform
◦ Local authorities
◦ National authorities
◦ International au...
 Recall
◦ Designate a person to handle recalls
◦ Written procedure
◦ Define circumstances for recall
◦ Define
 Person to...
 Conduct & Record Self Inspections
 Self Inspections should monitor the
implementation of and compliance with this
guide...
This presentation was compiled from freely
available resources like the website of EU , EMA ,
specifically “Guidelines on ...
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Good distribution practices for API's

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The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.

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Transcript of "Good distribution practices for API's"

  1. 1. This presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 3/29/2015 1
  2. 2. This presentation is compiled from freely available resources like the website of EU , EMA , specifically “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use” “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 3/29/2015 2 Drug Regulations : Online Resource for Latest Information
  3. 3.  “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”  Published in February 2012  Comments were open till February 2013.  Final guidance published on in March 2015.  This presentation gives a summary of this guidelines. 3/29/2015 3 Drug Regulations - Online Resource latest information.
  4. 4.  Based on the fourth paragraph of Article 47 of Directive 2001/83/EC  Follow principles of ◦ EudraLex Volume 4, Part II, Chapter 17, with regard to the distribution of active substances and ◦ Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use 3/29/2015 4 Drug Regulations - Online Resource latest information.
  5. 5.  Provide stand-alone guidance on Good Distribution Practice (GDP)  To be followed by ◦ Importers and distributors of active substances for medicinal products for human use. ◦ Distributors of active substances manufactured by themselves.  Complement rules on distribution set out in the guidelines of EudraLex Volume 4, Part II 3/29/2015 5 Drug Regulations - Online Resource latest information.
  6. 6.  Commission Delegated Regulation (EU) No 1252/2014 (3) and EudraLex Volume 4, Part II are applicable to ◦ Any manufacturing activities in relation to active substances including  Re-packaging,  Re-labelling or  Dividing up 3/29/2015 6 Drug Regulations - Online Resource latest information.
  7. 7. Additional requirements apply to the importation of active substances, as laid down in Article 46b of Directive 2001/83/EC. 3/29/2015 7 Drug Regulations - Online Resource latest information.
  8. 8. These Guidelines are applicable as of September 21 , 2015. 3/29/2015 8 Drug Regulations - Online Resource latest information.
  9. 9.  Applicable to distribution of active substances, ◦ Defined in Article 1(3a) of Directive 2001/83/EC, for medicinal products for human use. 3/29/2015 9 Drug Regulations - Online Resource latest information.
  10. 10.  Active substances, ◦ An active substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis. 3/29/2015 10 Drug Regulations - Online Resource latest information.
  11. 11.  Distribution of active substances shall comprise all activities consisting of ◦ Procuring ◦ Importing ◦ Supplying or exporting active substances ◦ Brokering  Guidelines do not apply to intermediates of active substances. 3/29/2015 11 Drug Regulations - Online Resource latest information.
  12. 12.  Develop and maintain a quality system  Set out responsibilities  Use process and risk management principles  Examples of quality risk management ◦ EudraLex Volume 4, Part III: GMP related documents ◦ ICH guideline on Quality Risk Management (ICH Q9). 3/29/2015 12 Drug Regulations - Online Resource latest information.
  13. 13.  Should be adequately resourced  Competent personnel  Suitable and sufficient premises  Equipment and facilities 3/29/2015 13 Drug Regulations - Online Resource latest information.
  14. 14.  Quality System should ensure that: 1. Active substances are procured, imported, held, supplied or exported in a way that is compliant with the requirements of GDP for active substances 2. Management responsibilities are clearly specified 3. Active substances are delivered to the right recipients within a satisfactory time period 4. Records are made contemporaneously 3/29/2015 14 Drug Regulations - Online Resource latest information.
  15. 15.  Quality System should ensure that: 4. Deviations from established procedures are documented and investigated; 5. Appropriate corrective and preventive actions, commonly known as ‘CAPA’, are taken to correct deviations and prevent them in line with the principles of quality risk management; 6. Changes that may affect the storage and distribution of active substances are evaluated. 3/29/2015 15 Drug Regulations - Online Resource latest information.
  16. 16.  Development & Modification of Quality System ◦ Consider the size, structure and complexity of the distributor’s activities 3/29/2015 16 Drug Regulations - Online Resource latest information.
  17. 17.  Designated person ◦ Appoint at each location where distribution activities are performed ◦ Should have defined authority and responsibility ◦ Should ensure that a quality system is implemented and maintained ◦ Should fulfil his responsibilities personally ◦ Designated person can delegate duties but not responsibilities 3/29/2015 17 Drug Regulations - Online Resource latest information.
  18. 18.  Specify & document responsibilities of all  Should have the appropriate competence and experience  Should ensure that active substances are properly handled, stored and distributed. 3/29/2015 18 Drug Regulations - Online Resource latest information.
  19. 19.  Training ◦ Initial ◦ Continuing / ongoing ◦ Relevant to their role ◦ Based on written procedures ◦ In accordance with a written training programme ◦ Cover requirements of GDP ◦ Keep record of all training ◦ Assess effectiveness of training ◦ Document effectiveness assessment 3/29/2015 19 Drug Regulations - Online Resource latest information.
  20. 20.  Documentation ◦ Paper or in electronic data ◦ Written procedures ◦ Instructions ◦ Contracts ◦ Records ◦ Readily available ◦ Retrievable. ◦ Made available to competent authorities on request 3/29/2015 20 Drug Regulations - Online Resource latest information.
  21. 21.  Documentation ◦ Sufficiently comprehensive w r t distributor’s activities ◦ In a language understood by personnel ◦ Clear, unambiguous language ◦ Free from errors 3/29/2015 21 Drug Regulations - Online Resource latest information.
  22. 22.  Documentation ◦ Any alteration should be signed and dated ◦ Any alteration should permit the reading of the original information ◦ Reason for the alteration should be recorded ◦ Ready access to all responsible & accountable 3/29/2015 22 Drug Regulations - Online Resource latest information.
  23. 23.  Written  Describe distribution activities which affect the quality of the active substances ◦ Receipt and checking of deliveries ◦ Storage ◦ Cleaning 3/29/2015 23 Drug Regulations - Online Resource latest information.
  24. 24.  Describe distribution activities which affect the quality of the active substances ◦ Maintenance of the premises & Pest control ◦ Recording of the storage conditions ◦ Security of stocks on site & of consignments in transit ◦ Withdrawal from saleable stock ◦ Handling of returned product ◦ Recall plans 3/29/2015 24 Drug Regulations - Online Resource latest information.
  25. 25.  Procedures ◦ Approved ◦ Signed ◦ Dated  By person responsible for the quality system 3/29/2015 25 Drug Regulations - Online Resource latest information.
  26. 26.  Procedures ◦ Use only valid and approved procedures ◦ Review regularly ◦ Keep up to date ◦ Apply version control ◦ Implement document control system ◦ Prevent inadvertent use of the superseded version ◦ Remove superseded or obsolete procedures & archive 3/29/2015 26 Drug Regulations - Online Resource latest information.
  27. 27.  Records ◦ Clear ◦ Be made at the time each operation is performed ◦ Significant activities or events are traceable ◦ Retained for at least 1 year after the expiry date ◦ For actives with retest dates for at least 3 years after the batch is completely distributed 3/29/2015 27 Drug Regulations - Online Resource latest information.
  28. 28.  Records that should be retained and be available include: (i) Identity of supplier, original manufacturer, shipping agent and/or consignee (ii) Address of supplier, original manufacturer, shipping agent and/or consignee (iii) Purchase orders (iv) Bills of lading, transportation and distribution records; (v) Receipt documents (vi) Name or designation of active substance (vii) Manufacturer’s batch number (viii) Certificates of analysis, including those of the original manufacturer; (ix) Retest or expiry date 3/29/2015 28 Drug Regulations - Online Resource latest information.
  29. 29.  Records ◦ Each purchase and sale ◦ Date of purchase or supply ◦ Name of the active substance ◦ Batch number ◦ Quantity received or supplied ◦ Name and address of the supplier ◦ Name & address of the original manufacturer, if not the same ◦ Name & address of the shipping agent and/or the consignee ◦ Ensure traceability of the origin and destination of products 3/29/2015 29 Drug Regulations - Online Resource latest information.
  30. 30.  Records  Records that should be retained and be available include: (i) Identity of supplier, original manufacturer, shipping agent and/or consignee; (ii) Address of supplier, original manufacturer, shipping agent and/or consignee; (iii) Purchase orders; (iv) Bills of lading, transportation and distribution records; (v) Receipt documents; (vi) Name or designation of active substance; (vii) Manufacturer’s batch number; (viii) Certificates of analysis, including those of the original manufacturer; (ix) Retest or expiry date. 3/29/2015 30 Drug Regulations - Online Resource latest information.
  31. 31.  Premises & Equipment ◦ Suitable and adequate ◦ Ensure proper storage & protection from contamination  Narcotics  Highly sensitising materials  Materials of high pharmacological activity or toxicity  Distribution of active substances. 3/29/2015 31 Drug Regulations - Online Resource latest information.
  32. 32.  Premises & Equipment ◦ Suitably secure to prevent unauthorised access ◦ Installed with monitoring devices to guarantee the quality attributes ◦ Monitoring devices should be calibrated ◦ Approved & written schedule ◦ Use of certified & traceable standards 3/29/2015 32 Drug Regulations - Online Resource latest information.
  33. 33.  Orders ◦ Manufacturer, importer or distributor of API established in the EU should be registered according to Article 52a of Directive 2001/83/EC 3/29/2015 33 Drug Regulations - Online Resource latest information.
  34. 34.  Receipt  Reception area ◦ Protect deliveries from prevailing weather conditions during unloading ◦ Separate from the storage area. 3/29/2015 34 Drug Regulations - Online Resource latest information.
  35. 35.  Receipt  Examine deliveries (i) Containers are not damaged; (ii) All security seals are present with no sign of tampering; (iii) Correct labelling, including correlation between the name used by the supplier and the in-house name, if these are different; (iv) Necessary information, such as a certificate of analysis, is available; and (v) The active substance and the consignment correspond to the order. 3/29/2015 35 Drug Regulations - Online Resource latest information.
  36. 36.  Receipt ◦ Quarantine consignment  Physical  Equivalent Electronic system ◦ Broken seals ◦ Damaged packaging ◦ Suspected of possible contamination ◦ Investigate the cause of the issue 3/29/2015 36 Drug Regulations - Online Resource latest information.
  37. 37.  Receipt ◦ Specific storage measures  Narcotics  Products requiring a specific storage  Temperature or humidity ◦ Identify immediately ◦ Store in accordance with written instructions ◦ Follow relevant legislative provisions 3/29/2015 37 Drug Regulations - Online Resource latest information.
  38. 38.  Receipt ◦ Falsified A P I ◦ Segregate  Physically or  Using an equivalent electronic system ◦ Inform the national competent authority of the country in which he is registered. 3/29/2015 38 Drug Regulations - Online Resource latest information.
  39. 39.  Receipt ◦ Rejected materials ◦ Identify ◦ Control ◦ Quarantined  Prevent use in manufacturing  Prevent further distribution. ◦ Records of destruction activities should be readily available. 3/29/2015 39 Drug Regulations - Online Resource latest information.
  40. 40.  Storage ◦ Store under conditions specified by the manufacturer ◦ Controlled temperature and humidity when necessary ◦ In a manner to prevent contamination and/or mix up ◦ Monitor storage conditions ◦ Maintain records ◦ Quality responsible should review records ◦ Qualify storage area for specific storage conditions ◦ Operate area within specified limits 3/29/2015 40 Drug Regulations - Online Resource latest information.
  41. 41.  Storage Facility / Area ◦ Clean ◦ Free from litter, dust and pests ◦ Implement precautions against  Spillage  Breakage,  Attack by micro-organisms  Cross-contamination. 3/29/2015 41 Drug Regulations - Online Resource latest information.
  42. 42.  Storage ◦ Implement stock rotation,  ‘first expiry (retest date), first out’, ◦ Check regularly that the system is operating correctly. ◦ Validate electronic warehouse management systems ◦ Separate Active substances beyond their expiry date from approved stock  Physical separation or use an equivalent electronic ◦ Ensure that this material is not supplied 3/29/2015 42 Drug Regulations - Online Resource latest information.
  43. 43.  Contracted Storage & Distribution ◦ Ensure that contractor  Knows his responsibilities  Follows the appropriate storage and transport conditions ◦ Have a written contract  Clearly establish duties of each party.  Do not permit further sub contracting without written authorisation. 3/29/2015 43 Drug Regulations - Online Resource latest information.
  44. 44.  Deliveries to customers ◦ Supplies within the EU  Only by distributors registered according to Article 52a of Directive 2001/83/EC 3/29/2015 44 Drug Regulations - Online Resource latest information.
  45. 45.  Deliveries to customers ◦ Transport in accordance with conditions specified by the manufacturer ◦ Transport should not adversely quality. ◦ Maintain product, batch and container identity at all times. ◦ All original container labels should remain readable. ◦ Implement a system for identification & recall 3/29/2015 45 Drug Regulations - Online Resource latest information.
  46. 46.  Transfer of Information ◦ Notification to customers  Any adverse information or event  Potential to cause an interruption to supply 3/29/2015 46 Drug Regulations - Online Resource latest information.
  47. 47.  Transfer of Information ◦ Regulatory Information ◦ Product Quality Information  Distributor responsible for transfer  From an active substance manufacturer to the customer  From the customer to the active substance manufacturer 3/29/2015 47 Drug Regulations - Online Resource latest information.
  48. 48.  Transfer of Information ◦ Distributor to provide information from the manufacturer to the customer :  Name and address of the original active substance manufacturer  Batch number(s) supplied  Copy of the original certificate of analysis  Identity of manufacturer to competent authorities upon request  Original manufacturer can respond to the competent authority directly or through its authorised agents  C OA  Refer section 11.4 of Part II of Eudralex Volume 4. 3/29/2015 48 Drug Regulations - Online Resource latest information.
  49. 49.  Returns  Identify  Quarantine  Conduct investigation 3/29/2015 49 Drug Regulations - Online Resource latest information.
  50. 50.  Active substances should only be returned to saleable stock if:  The active substance is in the original unopened container(s) and in good condition  It is demonstrated that the active substance have been stored and handled under proper conditions  The remaining shelf life period is acceptable  They have been examined and assessed by a person authorised to do so 3/29/2015 50 Drug Regulations - Online Resource latest information.
  51. 51.  Maintain records of returns.  Include following details in the records:  Name and address of the consignee  Active substance batch number and quantity returned  Reason for return  Use or disposal of the returned active substance 3/29/2015 51 Drug Regulations - Online Resource latest information.
  52. 52.  This assessment should take into account  The nature of the active substance  Any special storage conditions it requires  The time elapsed since it was supplied.  Give special attention to products requiring special storage conditions.  Seek advice from the manufacturer of the active substance. 3/29/2015 52 Drug Regulations - Online Resource latest information.
  53. 53.  Release to active stock ◦ Only by appropriately trained and authorised personnel ◦ Place such that the 'first expiry (re-test date) first out' system operates effectively 3/29/2015 53 Drug Regulations - Online Resource latest information.
  54. 54.  Complaints ◦ May be received orally or in writing ◦ Record all complaints ◦ Investigate according to a written procedure ◦ Review Quality Complaint with manufacturer 3/29/2015 54 Drug Regulations - Online Resource latest information.
  55. 55.  Complaints ◦ Determine need for further action  With other customers  With the competent authority  Or both. ◦ Conduct Investigation ◦ Document investigation 3/29/2015 55 Drug Regulations - Online Resource latest information.
  56. 56.  Complaint records should include: ◦ Name and address of complainant ◦ Name (and, where appropriate, title) and phone number of person submitting the complaint ◦ Complaint nature (including name and batch number of the active substance) ◦ Date the complaint is received ◦ Action initially taken (including dates and identity of person taking the action) ◦ Any follow-up action taken ◦ Response provided to the originator of complaint (including date response sent) ◦ Final decision on active substance batch or lot 3/29/2015 56 Drug Regulations - Online Resource latest information.
  57. 57.  Retain records of complaints  Take appropriate corrective action  Evaluate ◦ Trends ◦ Product related frequencies ◦ Severity  Make these records available to competent authorities 3/29/2015 57 Drug Regulations - Online Resource latest information.
  58. 58.  Responsibility of Original Manufacturer ◦ Distributor may refer to Original Manufacture ◦ Distributor record should include Manufacturer response ◦ Record the date and information provided by original manufactuer 3/29/2015 58 Drug Regulations - Online Resource latest information.
  59. 59.  Serious or Potentially life-threatening situation  Inform ◦ Local authorities ◦ National authorities ◦ International authorities ◦ Obtain their advice 3/29/2015 59 Drug Regulations - Online Resource latest information.
  60. 60.  Recall ◦ Designate a person to handle recalls ◦ Written procedure ◦ Define circumstances for recall ◦ Define  Person to evaluate information  How to initiate a recall  Whom to inform about recall  How to treat recalled material 3/29/2015 60 Drug Regulations - Online Resource latest information.
  61. 61.  Conduct & Record Self Inspections  Self Inspections should monitor the implementation of and compliance with this guideline. 3/29/2015 61 Drug Regulations - Online Resource latest information.
  62. 62. This presentation was compiled from freely available resources like the website of EU , EMA , specifically “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use” “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 3/29/2015 62 Drug Regulations : Online Resource for Latest Information

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