AUDITS AND REGULATORY COMPLIANCE

SEMINAR ON

AUDIT OF WARHOUSE AND WEIGHING

UNDER THE GUIDANCE

OF
Dr. Shrinivas S. Savale

BY
Priyal Shah
(172280824007)
1
M.Pharm, QUALITY ASSURANCE (SEM- 2)
 Table of Contents

• Audit
• Warehouse
-Objective
-Ideal Warehouse
-Checklist
• Weighing
-Checklist
• Reference
 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

Auditor : A person who has appropriate qualifications and perform audit

Steps To Perform Quality 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.
1.
2.
Receipt of products Transfer into the
from Manufacturing warehouse.
plant.

3. 4.
Placement at Regrouping products
designated place

5. 6.
Storing products in the
Transferring on warehouse till delivery
transport vehicle. to ultimate consumer.
Objective To Audit Warehouse

The objective of the audit is to assess whether processes

and controls are sufficient to support effective and
efficient warehouse management.

Effective: Producing a result

that is wanted.

Efficient: Capable of producing

desired results without wasting
materials, time, or energy.
Ideal Warehouse

• The warehouse should be of sufficient size to allow

handling and storage of products in a manner that does
not result in product contamination.
• The warehouse should be properly ventilated to
prevent condensation.
• Openings leading to exterior should be meshed to
prevent the entry of pests.
• Floors should be non-slipy, evenly graded to prevent
water stagnation.
• Floors are to be constructed using impervious, non-
toxic, non-absorbent and crack resistant materials.
• Stocks are rotated according to the
First In First Out - FIFO system
First Expire First Out - FEFO system and adequate
records for the system must be kept.
• Good housekeeping practices should be observed at
all times.
• Eating, drinking, smoking, chewing of gum or
tobacco, littering and other undesirable behaviour at
designated areas in the premises is prohibited.
• Any person who has or appears to have an infectious
disease, open lesion, including boils, sores, or
infected wounds, or any other abnormal source of
microbial contamination must be excluded from any
operations.
• There should be pest management practices in place
to prevent the harborage and breeding of pests on the
grounds and within the warehouse facility.
• No pets including birds and animals are to be kept
within or around the warehouse premises.
• The personnel working in the warehouse should be
properly gowned.
• Adequate lightings - to permit effective cleaning and
to ensure that the storage operations can be carried
out in a hygienic manner.
Checklist for Audit
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?
• 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?
 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?
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?
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?
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?
• 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?
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?
• 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 ?
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?
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?

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?
FIRE PROTECTION
• Is all fire fighting 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?
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?
• 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?
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.
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?
Summary
 WEIGHING

Weighing means - To find out how heavy the

material (to be weighed is) by typically using
scales.

For Non Sterile For Sterile

 Checklist
• 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?
• 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 materials and packaging
materials?
• Are only the relevant raw materials, intermediate products
and bulk products located within the dispensing area?
• 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
• https://en.wikipedia.org/wiki/Auditor (06-03-18, 21:58)
• Quality Assurance audits in pharma industries, Rasika
Walunj, Morden college of pharmacy, moshi slideshare
(slide no:7-11)(06-03-2018;22:36)
• https://www.slideshare.net/Dolita-Shah/quality-audit
(slide no:16) (06-03-2018;22:46)
• http://www.warehousingforum.com/news/2003_08.pdf ,
volume 18, number 9, 2003(Reasons to audit ; 21-02-
18,23:08)
• https://blog.kencogroup.com/why-an-internal-warehouse-
quality-audit-is-critical-to-your-warehouse-
operations(myths; 21-02-18,23:54)
• https://www.ava.gov.sg/docs/default-source/tools-and-
resources/resources-for-
businesses/goodwarehousingpractices27sept11 (ideal
points for audit, 14-03-2018)
• http://www.crs-csex.forces.gc.ca/reports-
rapports/2014/208p0967-eng.aspx(method; 21-02-18)
• https://distributiondesign.com/logistics-consultant-
services/operational-audit-operational-
assessment/(operational audit areas, audit report)
• http://www4.ncsu.edu/~kay/Material_Handling_Equipme
nt.pdf (material handling in warehouse)
• https://www.pharmaguideline.com/2012/05/gmp-audit-
check-list-weighing-and.html(06-4-2018)
 Videos

• https://www.youtube.com/watch?v=LggqVNZN3M4 –
warehouse picking
• https://www.youtube.com/watch?v=It7qr6fga3c