Good Warehousing Practices (GWH) in Pharmaceutical Industry

1. GOOD WAREHOUSING PRACTICES
(GWP)
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Mr. Swapnil Karale
-M.Sc. DPQCQAM, DDRA
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2. ABOUT TRAINER(MR. SWAPNIL KARALE)
Mr. Swapnil is managing, leading & positively contributing in the area of
documentation, systems set up and enhancements, quality assurance, auditing,
validations, calibrations in a leading pharma company & specialized in auditing,
training & consultation.
He is having 10+ years of industrial experience in various pharmaceutical industries
like Sun Pharma, IPCA Group, Alkem Laboratories in various dosage forms such as
tablets, capsules, dry syrup, powder for oral suspension, suppositories, etc. and he
is qulified cGMP auditor.
He has hands on experience in In Process Quality Assurance,
Validation/Qualification Process, GMP auditing & overall QMS System including
change control & deviations handling. During this tenure with pharma industry, he
has been closely involved in regulatory affairs /development activities. He has faced
multiple regulatory audits including US-FDA, MHRA, TGA & WHO-Geneva
successfully. He also have a wide experience in Integrated Management System
implementation & clearing the management standards audits like ISO 9001 / 14001
& OHSAS 18001 without any nonconformity with world’s stringent certification body.
He has trained many pharma professionals on QMS & Validation Techniques. 2
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3. AGENDA
1. Premises
2. Security
3. Temperature and humidity control
4. Equipment
5. Personnel
6. Sanitation
7. Receipt of incoming goods
8. Warehousing of FG and Dispatch of FG
9. Packing for transportation
10. Transport
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4. PREMISES
 Premises should be of suitable size and construction to
facilitate cleaning, maintenance and orderly, segregated
storage
 Storage areas must be designed to provide adequate:
 Ilumination
 Ventilation
 Temperature
 Sanitation
 Humidity
 Space
 Equipment
 security conditions
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5. PREMISES
 Each material should be stored separate from other
materials to avoid the risk of cross contamination
 Incoming materials should be Quarantine until approved
by the responsible person
 A segregated area must be provided for returned,
recalled and rejected goods prior to a decision on further
action
 A secure, segregated area must be provided for the
storage of controlled drugs
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6. SECURITY
 Storage areas should be provided with security to prevent
theft or unauthorised entry
 Maintain a control of who may enter the facilities
 Establish system for controlling access to the facility
(including all entrances and exits)
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7. TEMPERATURE AND HUMIDITY CONTROL
 All materials must be stored at appropriate conditions as
stated on the label of the material
 The temperature of all storage areas should be regularly
monitored
 Controlled temperature storage areas should be equipped
with recorders and devices which indicate when the
specific temperature range has not been maintained
 A written procedure must specify the action to be taken
when this occurs
 Control should be adequate to ensure that all parts of the
storage area are kept within the specified temperature
range
 Should always be a back up system in case main system
fails 7
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8. TEMPERATURE AND HUMIDITY CONTROL
 The humidity of all storage areas should be regularly
monitored and recorded
 If the product spec require a specific humidity, a written
procedure must specify the action to be taken when the
specified humidity range has not been maintained
 Establish a normal operating baseline of humidity if no
specific value is required
 Records of temperature and humidity in all storage areas
should be reviewed and retained by a designated
responsible person
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9. EQUIPMENT
 There should be a planned preventative maintenance
programme in place (i.e. RLAF, AHU etc.)
 Recording and control equipment should be verified &
calibrated in intervals by appropriate methods (i.e.
Electronic Balances, Thermo hygrometer, RLAF,
AHU,Dynamic pass box)
 Alarm set-points should be checked on periodic intervals
 A computerised system(SAP) used for stock
control/distribution should be validated
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10. PERSONNEL
 The organisation chart should be in place
 There should be a sufficient number of staff
 There should be clearly defined job description
 Personnel should be trained in relation to good storage and
distribution practice and to the duties assigned to them
 The current records of training should be in place
 The trainers should have established and approved
qualification
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11. ORGANIZATION CHART(STORES)
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Head Stores
Deputy
Manager Stores
Sr. Executive
Stores
Executive
Stores
Assistant Stores
Manager Stores
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12. SANITATION
 A written sanitation program should be in place indicating
the frequency and method of cleaning the facility(i.e. Area
cleaning SOP)
 A pest control program should be in place
 Smoking, eating and drinking should be permitted only in
segregated areas, and not in those areas used for the
storage and handling of final drug product
 Material spill must be promptly cleaned-up in accordance
with the relevant health and safety requirements for
materials
 Adequate toilet and changing facilities should be provided,
and they should be segregated from the main storage and
order assembly areas
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13. RECEIPT OF INCOMING GOODS
 It should be carried out according to approved adequate SOP:
 Visually examine delivery documents of the consignment (i.e.
delivery challan, LR Copy, excise invoice,COA etc.)The documents
should be essentially consist of following information (Name of
material, Name of manufacturer, batch no, manufacturing date,
expiry date, qty. etc.)
 Visually examine physical condition & verification of consignment for
damage.Cross verify container labels with documents, Batchwise
segregation
 reject product if damage or otherwise unfit for use
 If any discrepancies is observed in doc,material packing,vechicle
condition,then warehouse officer should bring notice this to head
warehouse & QA
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14. WAREHOUSING & DISPATCH OF FG
 It should be carried out according to approved adequate SOP:
 Storage area should be maintained or designed to ensure good
storage practice
 Finished product shippers should be kept on pallets batchwise in
defined high stacking to avoid fails down
 Stores area should be suitably secured and of sufficient capacity
to allow for the safe storage & handling.
 Storage area should be clean & dry and maintained within
acceptable temperature limit
 Record should be maintained of storage conditioned, Records of
temperature monitoring data should be available for review
 Prepare adequate shipping package to protect any damage of
goods, seal pack and provide relevant identification
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15. PACKING FOR TRANSPORTATION
Products should be packed in such a way that:
 the identification of the product is not lost,
 the product does not contaminate and is not contaminated
by other products or materials
 adequate precautions are taken against breakage
 products requiring controlled temperature storage should
be provided with insulated packs
 there should be in place documented evidence that the
insulated packs ensured adequate transport conditions
with regards to: product quantity,ambient temperature,
maximum delivery time.
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16. TRANSPORT
 Products should be transported in such a way that:
 The safety, identity, strength, quality of the product is not
lost
 The product is not contaminated by other products or
materials
 Adequate precautions are taken against breakage
 The product and its package are not subjected to
unacceptable degrees of heat, cold, light, moisture or
other adverse influences nor to attack by micro-organisms
or pests
 Drug products requiring controlled temperature storage by
appropriate specialised means or should be packed with
adequate insulation
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17. TRANSPORT
Documents should be provided to cover all shipments.
These document should include as minimum:
 name of the product
 quantity of the product
 special storage and handling instructions
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18. RECORDS
 Following records should be in place:
 receiving material (delivery challan,invoice,check list)
 issuing material (BMR/BPR issuance copy)
 FG (receiving packing list,outgoing invoice,delivery challan,ARE1
copy with authorised signature)
 Training
 monitoring temperature and humidity
 cleaning operation
 pest control
 calibration
 preventative maintenance
 Recall
 Complaints
 Inventory (Inward ,stock registers)
 log of signature (formats)
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19. REFERENCES
 Good manufacturing practices for pharmaceutical
products. In: Quality assurance of pharmaceuticals. A
compendium of guidelines and related materials. Volume
2. Good manufacturing practices and inspection.
 apps.who.int/medicinedocs/documents/s18675en/s18675
en.pdf
 www.who.int/medicines/areas/.../GoodDistributionPractice
sTRS957Annex5.pdf
 https://ec.europa.eu › ... › Public health › Medicinal
products for human use
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20. To get training material / to invite for training on this subject,
Write to ;
Mr. Swapnil A. Karale
Email : swara21032015@gmail.com
Mobile No.: +91 9637368948
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You learn from experience
You learn better from bad experience
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