Name: Patel Payal R.

Eno Roll: 201904103910010(M. Pharm 2ndsem)

Subject: Audits and Regulatory Compliance

Audit of warehouse and weighing

 What is an audit?
Quality audit is the process of systematic examination of a
quality system carried out by an internal or external auditor or
an audit team.
Types:
1. Internal Audit
2. External Audit
3. Regulatory Audit

 What is a warehouse?
Place where goods are kept is called –WAREHOUSE
Warehousing is a set of activities that are involved in receiving
and storing of goods and preparing them for Reshipment.

 Checklist for Audit of warehouse

1. RECEIVING
• Are warehouse operating procedures current and on file?
• Are receiving documents available at time shipment is
received?
• Are they adequate for complete identification of material in
the shipment?

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 • If not, is the fact reported so corrective action may be taken?
• Are items checked for description, quantity and condition at
the arrival of shipment?
• Are receiving reports being processed properly?
• Is management informed of any abnormal backlogs of
unprocessed receiving reports?

2. PRODUCT/ INVENTORY/ORDERS
• Are spot checks conducted to determine the location of the
material as reflected on the stock records?
• Are the stock records reflecting shelf-life information retained
in a follow-up file?
• Are the inspectors notified when shelf-life items are
scheduled for re-inspection?
• Are periodic spot checks conducted to verify the quantity and
condition of material indicated on the stock records?
• Is the proper procedure being used when discrepancies exist?
• Is material in storage reviewed periodically to determine the
necessity for reprocessing?
• Are orders received in sufficient detail to readily identify the
material that is to be withdrawn?
• Does a backlog of orders exist? If so, is management informed
of the fact?

3. SHIPPING
• Is any action taken to reconcile a shipment with the order?
• Are outbound shipments properly manifested?
• Are carriers promptly billed at the completion of loading?
• Are carrier tariffs being observed?
• What percentage of orders meets the promised delivery
date?

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4. STORING
• Are storage methods best suited to the characteristics of the
storage areas?
• Does the storage plan permit flexibility of operations and
provide for adequate small-lot storage space?
• Are stored materials adequately and accurately marked for
proper identification and easily located through use of the
locator file?
• Are materials of similar categories grouped together as much
as practicable?
• Are hazardous and flammable materials stored separately?
• Are materials stacked correctly to ensure the greatest safety
to personnel, protection of material and accessibility?
• Are all materials that are not palletized raised off the floor by
use of dunnage?
• Are open or damaged cases of cartons removed from stacks
and repacked?
• Are packing, crating and other preparations for shipment
adequate?
• Are items generally properly packaged and processed prior to
receipt?
• Is an adequate inspection made of the condition of incoming
items?
• Are adequate and proper steps taken to care and preserve
storage items?

5. MATERIAL HANDLING EQUIPMENT (MHE)

• Is MHE utilized to the maximum?
• Is MHE adequate for a balanced operation?
• Is inadequate maintenance of equipment interfering with
operations?

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 • Could operations be made more efficient by exchanging one
type and size of equipment for another?
• Is MHE centrally controlled and properly distributed for
maximum utilization?
• Is an adequate checkout system in operation governing use of
MHE?
• Is available MHE the proper size and type for efficient
handling of items in storage?
• Are additional or different types of equipment needed?
• If so, have specific requirements been reported?
• Is all equipment maintained in good operating condition?
• Are routine adjustments and minor repairs made promptly?
• Are preventative maintenance inspections and lubrication
made on each MHE item?
• Is MHE being misused?
• Are thorough periodic checkups made of all motorized
equipment?
• Has any equipment been out of operation for an abnormal
period of time? Are such cases reported?
• Are MHE records maintained so information is readily
available to meet inventory and accounting requirements?

6. WAREHOUSE LAYOUT
• Is a diagrammatic plan of the warehouse layout available and
in use?
• Is it used to pre plan storage space?
• Are closed and open storage areas designated on the plan
and clearly marked?
• Is maximum storage space being utilized considering type of
commodities, cube, floor load capacity, aisle space and
accessibility?
• Is space used for non-storage activities kept to a minimum?

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 • loading and unloading, "in and out checking," and moving
materials can be done efficiently?
• Is aisle accessibility for inspection and withdrawals being
carried to an extreme?
• Is repeated re warehousing necessary due to excessive
honeycombing?
• Are sufficient pallets on hand?
• Are they of proper type and size?
• Are excess pallets reported as available for use elsewhere?
• Are receiving and shipping bays located and sized so that
loading and unloading, "in and out checking," and moving
materials can be done efficiently?

7. HOUSEKEEPING
• Are structures and grounds properly maintained? By whom?
• Are periodic inspections made of the storage facility to
determine any major repairs or construction needed to protect
the real property from abnormal depreciation?
• Are reports made to management of any overtaxing of
existing facilities that may require additional construction,
repairs or possible change in operating procedure?
• Are floors swept, stacks even, and general maintenance
performed?
• Are toilets, washrooms and locker rooms maintained in a
neat and sanitary condition?

8. ACCIDENT PREVENTION
• Are all accidents fully investigated, analyzed and reported
promptly and accurately?
• Are causes of accidents corrected immediately?
• Are first aid facilities adequately provided?
• Are trained first-aid personnel available at the facility?

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9. GUARD SERVICE
• Is guard service adequate for proper protection of real and
personal property?
• Does your contract alarm service provide responsive
protection?
• Have you tested their alarm service yourself?

10. FIRE PROTECTION

• Is all firefighting equipment conspicuously marked and readily
accessible?
• Are fire extinguishers, sprinkler systems and other protective
equipment inspected periodically and a record kept of the
inspection dates?
• Have personnel been instructed about the location and use of
available equipment as well as the method of notifying the
local fire department when necessary?
• Are scheduled inspections of the premises made to eliminate
fire hazards and enforce precautionary measures?
• Is the proper type of fire protection available?

11. SAFETY
• Is there a safety and accident prevention program in effect?
• Does management take an active interest and participate?
• Are combustible and flammable materials segregated from
other materials?
• Are supervisory personnel safety conscious and do they
understand safety and accident prevention methods?
• What is the attitude of employees to safety enforcement?
• Is there a job training program in effect?

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 • If so, are employees instructed in the use of safety methods
on their particular jobs and what they are to do in an
emergency?
• Are "no smoking," "no trespassing" and other safety signs
adequately displayed?
• Are safety devices provided and do personnel use protective
clothing?
• Have safety guards or other safety devices been removed or
rendered ineffective?
• Are proper safety measures taken when operating all
materials handling equipment?
• Are preventive maintenance operations effective?
• Are safety methods strictly enforced in handling and storing
materials and in housekeeping practices?
• Are special safety measures used in the care and handling of
all hazardous materials?

12. PERSONNEL
• Are personnel qualified to perform their assigned functions?
• Have administrative personnel received training in correct
preparation of forms, reports and other clerical duties?
• Are there any labor and/or management problems?
• Is there an accurate timekeeping record of labor hours?
• Are time and attendance records accurate and properly
maintained?
• Has the use of sick and annual leave been explained to
employees?
• too many too few Are there too many or too few employees
in relation to the average warehousing operational workload?
• Are seasonal workloads a factor?
• high low Is employee morale high? Low? Give the reasons.

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13. SUPERVISION
• Do supervisors properly plan and schedule work?
• Are daily conferences held with key operating personnel to
discuss warehouse problems and overall planning of
warehousing activities?
• Are weekly conferences held with key operating personnel to
discuss warehousing problems and overall planning of
warehousing activities?
• Is warehouse labor used to the best advantage?
• Are crews balanced?
• Are warehouse supervisors, checkers, materials handling
equipment operators and other personnel adequately trained
for their particular job?
• Are periodic checks made by supervisory personnel to see if
there is idling or lagging on the job?

 WEIGHING
Weighing means - To find out how heavy the material (to be
weighed is) by typically using scales.

 Checklist for audit of weighing

• Is the area equipped to avoid cross-contamination and

physically separated from the other rooms by walls or other
type of separation?
• Are lighting and ventilation adequate?
• Is there temperature and humidity control, where required?
• Are weighing and dispensing area maintained in a clean
condition?
• Are sterile raw materials weighed and dispensed in the sterile
area?

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• Is the area adequately staffed?
• Is there proper supervision in the area?
• Have the personnel received GMP training?
• Do the personnel receive up-dated training?
• Are personnel wearing appropriate clothing?
• Is protective clothing (gloves, caps, masks etc.) used during
the weighing operations?
• Are the utensils used for weighing (receptacles, scales,
hoppers, spatulas, pipettes etc.) properly cleaned after each
use?
• Are these utensils kept in an appropriate place which is free
from contamination?
• Are the scales and balances used for weighing calibrated
regularly?
• Are these recorded?
• Are records for these calibrations maintained?
• Are the containers of the raw materials to be weighed
cleaned before being opened?
• After weighing, are these containers well sealed?
• Are raw materials or components for each batch properly
identified and segregated after weighing?
• Does this Identification Include:
a) The name of the raw materials or component?
b) The batch and another control number of the raw material
or component?
c) The batch number of the drug product to be manufactured?
d) The quantity that was weighed?
• Are there written procedures for handling, weighing, counting
and dispensing a raw material and packaging materials?
• Are only the relevant raw materials, intermediate products
and bulk products located within the dispensing area?

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 • After weighing, dispensing and labeling, are raw materials,
intermediate products and bulk products transported and
stored in a manner that will preserve its integrity until further
processing?
• Prior to weighing and dispensing, is each container of raw
materials checked for proper labeling, including the approval
label from quality control?
• Are capacity, accuracy and precision of weighing and
measuring equipment used appropriately to the number of
materials to be weighed or measured?

 REFERENCE
1. https://www.pharmaguideline.com/2017/09/checklist-for-
audit-in-warehouse.html
2. https://www.scribd.com/presentation/410660632/3-
warehouse-audit-pptx

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