The document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management control. It provides 11 sections that outline CGMP policies related to personnel, premises, equipment, sanitation, storage, production, packaging, quality control, documentation, self-inspection, and product complaints. It also discusses the objectives of inventory control to minimize costs and disruption while ensuring adequate stock. Various techniques for inventory control are analyzed including ABC, VED, XYZ and SOS analyses.

1. OBJECTIVE AND POLICIES OF
CGMP
&
INVENTORY MANAGEMENT
CONTROL
PRESENTED BY : MEGHA RAMESH TONGE
M PHARM (DEPT OF PHARMACEUTICS )
HI-TECH COLLEGE OF PHARMACY ,CHANDRAPUR

2. CONTENT
 INTRODUCTION
 IMPORTANCE OF CGMP
 OBJECTIVES
 POLICIES OF OF CGMP
 INVENTORY CONTROL
 OBJECTIVES
 FUNCTIONS
 INVENTORY COST
 TECHNIQUES OF INVENTORY CONTROL

3. CURRENT GOOD MANUFACTURING PRACTICES
 CGMP refers to the regulation which establish by the US Food and Drug
Administration .
 This assure that drug product meet their quality standard .
 CGMP provide for system that assure proper design monitoring and
control of manufacturing processes and facilities
 The regulation make sure that the product is safe for use and that it has
the ingredients and strength it claim to have .
 The approval process for new drug and generic drug marketing
application include a review of the manufacture compliance with the c
GMP .
 FDA can issue a warning letter or initiate other regulatory action agains
a company that’s fails to comply with the regulations

4. This includes establishing strong quality management system ,
obtaining appropriate quality raw material , detecting and
investigating product quality deviation and maintaining
reliable testing laboratories
This formal system controls at a pharmaceutical company if
adequataly put into practice , helps to prevent in
contamination ,mix –ups ,deviations , failures and errors

5.  Title 21 of code of federal regulation (CFR) : FOOD DRUG AND
COSMETIC ACT
 The US GMP regulation are divided into two parts : 210 and 211 of
title 21
 Part 210 : “current good manufacturing practices in manufacturing
processing and packing or holding of drugs “ basically it provide the
framework for the regulation
 Part 211 : “current good manufacturing practices for finished
pharmaceuticals

6. IMPORTANCE OF CGMP
 It prevent the product mix ups , contamination , deviations ,
failures and errors which assures that the drug products meets the
required quality standard .
 It assures that the drug are manufacture under good conditions ,
equipment is properly maintained and calibrated , by who are
qualified and fully trained and processes that are reliable and
reproducible

7. OBJECTIVE OF THE CGMP
 Ensure that products are consistently manufactured and controlled to
the specified quality .
 Concerned with all aspects of production and quality control
 In the manufacture of cosmetics products of specified quality
 Ensure that the consumer receives products of specified quality
 CGMP regulation assures the identity , strength , quality and purity of
drug products

8. CURRENT GMP POLICIES
Section 1 : PERSONNEL
 There shall be an adequate number of personnel at all levels having
knowledge, skills and capabilities relevant to their assigned functions, in
good mental and physical health to be able to execute their duties.
 The organizational structure of the company shall be such that the
production and the quality assurance are headed by different managers like
quality control manager, production control manager ect.
 All employees who are engaged in the manufacturing activities shall be
trained properly that the employees perform in accordance with the
principles of Current Good Manufacturing

9. Section 2 : PREMISES
 The premises for manufacturing shall be of suitable size , design ,
construction and location to facilitate proper operation , cleaning and
maintenance .
 The individual working area shall be adequate so that any risk of
confusion ,cross- contamination will adversely affect the quality of
drugs and devices will be avoided .
 Production areas shall be ventilated with air control facilities
 Avoid exposed overhead roof joints , pipes and ducts
 The condition of buildings shall be reviewed regularly , and repaired
where necessary

10. Section 3 : EQUIPMENTS
 Equipment used in the manufacturing of drug products shall be of appropriate
design and construction , adequate size .
 It should be properly installed in order to assure product quality and process
reproducibility and to facilitate its cleaning and maintenance
 Equipment shall be subjected to regular maintenance checks at appropriate
intervals to prevent malfunctions or contamination
 Written procedures shall be established and followed for maintenance of
equipment .
 Validation shall be conducted following a validation protocol

11.  Section 4 : SANITATION AND HYGIENE
 The sanitation and and hygiene program cover personnel , premises
,equipment and apparatus , production materials and containers and
anything that could become a source of contamination to the product
 It should be validate and periodically assessed to ensure that the
effectiveness of the operation
 Direct contact shall be avoided between the operator and raw materials
,intermediate or bulk products .
 Records of cleaning , sanitizing ,sterilization and inspection shall be
maintained.

12.  Section 5 : STORAGE OF STARTING AND PACKAGING
MATERIALS AND FINISHED PRODUCTS
 Materials shall be stored in an order to prevent any risk of mix-up or
contamination and to facilitate inspection and maintenance
 The materials shall be stores under suitable environmental condition
 All raw material packaging material , intermediate and bulk products
return to storage areas shall be properly documented and reconciled.
 Rejected raw materials and packaging material shall not be store
together with approved material
 The first expiry first out system (FEFO) on approved raw materials shall
be used

13.  Section 6 : PRODUCTION
 Production shall follow defined procedures capable to provide assurance that
drug products to confirm their specification
 Manufacturing facilities and method shall be design to prevent cross
contamination
 process validation
 the presence in a drug product of any contaminant is unacceptable .
 A batch and/or lot numbering system applied to a processing state and finished
product
 Section 7 : PACKAGING
 Packaging operation shall be performed under strict control to protect the
identity , integrity and quality of the final package .
 All packaging operations shall proceed in accordance with SOP .

14.  Section 8 : FINISHED PRODUCT QUARANTINE AND
DELIVERY TO WAREHOUSE
 Finished product quarantine is the last point of control before the
product enters the warehouse and available for distribution to the
market
 Strick control shall be maintained to ensure that the product and its
packaging records meet all specified requirements before release to
the warehouse
 Written procedures should be maintained for the transfer of finished
product into the quarantined area ,and subsequent transfer to the
finished good warehouse

15.  Section 9 : QUALITY CONTROL
 Quality control is an essential part of good manufacturing practices
to provide assurance that the products will be consistently of a
quality appropriate to their intended use
 An independent quality control unit shall be established .
 A quality control system shall be developed to ensure that finished
products contain the correct materials of specified quality and
quantity and are manufactured under proper conditions following
standard procedures
 Quality control involves all analytical functions conducted in the
laboratory , including sampling , inspecting and testing of starting
materials , intermediate , bulk and finished product

16.  Section 10 : DOCUMENTATION
 Documents shall be prepared and designed carefully for easy ,
correct and effective use .
 Documents shall contain records of activities within production,
quality control, equipment maintenance, warehouse, distribution
and other specific activities related to Good Manufacturing Practices
 A master production document should include the product name,
dosage form, strength and description, the writer’s name and
description, name of verifier and list of document distribution.
 Batch processing Record
 Master packaging procedure

17.  Section 11: SELF INSECTION
 The purpose of self-inspection is to evaluate the manufacturer’s is to
evaluate the manufacturer’s compliance with Good Manufacturing
practices on all aspects of production and quality control.
 Self-inspection shall be preformed routinely and corrective actions shall
be implemented.
 A team consisting of personnel who can evaluate the implementation of
GMP objectively shall be appointed .
 The procedure and record for self inspection shall be documented

18.  Section 12 : GUIDELINE FOR HANDLING OF PRODUCT
COMPLAINT , PRODUCT RECALL AND OR RETURNED
PRODUCT
 A product complaint and report may relate to the quality , adverse
reaction or other therapeutic effect of the product
 A follow up action shall be taken after investigation and evaluation
of the product complaint and report
 A product recall is a process of withdrawing one or more batches or
all of a certain product from market distribution
 A returned product is a finished product which is already in
distribution and return to the manufacturer due to complaint ,
damage , expiration , validity or other reason

19. INVENTORY MANAGEMENT AND
CONTROL
 Inventory control is the process by which inventory is measured and
regulated according to predetermine norms such as safety stock , minimum
level ,order level etc
 Inventory means all the raw materials ,semi processed materials and
finished goods etc .
 Inventory management is essential to maintain a large size inventory for
smooth and efficient production and also for sales operation

20. OBJECTIVE OF INVENTORY CONTROL
 To minimise the possibility of disruption in the production schedule for
want of raw materials , consumables ,spares and other store item .
 To keep down the capital investment in the inventories.
 To ensure adequate stock to finished product to meet the deliver
requirement of the customer.
 To reduce the loss due to changes in prices of inventory items .
 To facilitate the intermittent production of several products on the same
facility .
 To stabilize employment and improve labour relations by inventory of
human resourses and machine efforts.

21. FUNCTIONS OF INVENTORY CONTROL
 Minimise the carrying cost of the materials .
 Maintenance of sufficient stock of materials to take care of the
requirement during the period of short supply .
 Maintenance of sufficient stock of finished goods for smooth sales
operations.
 Protect the inventory against deterioration , obsolescence and
unauthorised use .
 To keep the inventories as low as possible which leads to consistent
price of market conditions .
 maintain the proper records and assess the stock position of the
materials

22. INVENTORY COSTS
• Cost of ordering the item .
• Expenses from raising the indent
,purchaserequisionby user department till the
execution of order
ORDERING
COST
• Cost incurred for holding the volume of inventory .
• Obsolescence cost , deterioration cost , taxes on
inventory, capital cost
INVENTORY
CARRYING COST
• Loss due to non availability of materials
• Break down /delay in production ,lost sales ,loss of
service to custom
OUT OF STOCK COST

23. TECHNIQUES OF INVENTORY CONTROL
 ABC Analysis
 VED Analysis
 SOS Analysis
 XYZ Analysis
 HML Analysis
 FSNO Analysis
 SDE Analysis

24. ALWAYS BETTER CONTROLANALYSIS
 Based on annual inventory values
PROCEDURE :
 List of all material used in the company .
 Work out their annual consumption value and money value .
 Multiply each items annual value by its money value .
 Arrange the item in the descending order
 Find out each items percentage of the total inventory .

25.  ADVANTAGES OF ABC ANALYSIS
 It ensure the better control over costly items.
 It helps in developing scientific method of controlling inventories .
 It helps in the maintaining the stock in a better way .
 Reducing the storage cost
 DISADVANTAGES OF ABC ANALYSIS
 Inconvenient to compute when item are in large number .
 Loose control of itesm causes shortage .
 Focuses on money value and not on functional importance causing
storage of critical items .
 Does not consider variation of prices with time

26. VED ANALYSIS
 Vital –Essential –Desirable
 Based on the utility of the material
FSN ANALYSIS
 Fastmoving –slow moving –non moving
 Based on the quantity ,rate of consumption ,pattern of issue for stores .
HML ANALYSIS
 High value – medium value –low value
 Based on their unit cost

27. XYZ ANALYSIS
 High stock value –medium stock value –low stock value
 Based on the value of inventory of materials .
GOLF ANALYSIS
 Government –ordinary –local – foreign
 Based on availability of nature of suppliers .
SOS ANALYSIS
 Seasonal – off seasonal
 Based on the seasonality of item

28. REFERENCES
 Current good manufacturing practices guidelines by karn gupta
www.youtube.com
 www.fda.gov .in
 How to practice GMPs by P.P. Sharma .
 www.wipo.int>laws
 Inventory control and management by C.D. J Waters.
 Metod of inventory controls available at
http://www.yourarticlelibrary.com

29. Thank You