MATERIAL MANAGEMENT

Present By - Mr. Akshay G. Kakde M. Pharm Ist sem

Guide By - Dr. Rupali Kale

Dr. D. Y. Patil IPSR Pimpri,411018

Content

Background.Aim of Material Management.Introduction.Purchasing. Raw Materials.Packaging Materials.Intermediate and Bulk Product.Finished Products.Rejected and Recovered Materials.

Content

Recalled Products.Returned Goods.Reagents and Cultured Media.Waste Materials.Reference Standards.Miscellaneous Materials.

Background

It is concerned with planning, organizing and controlling the flow of materials from their initial purchase through internal operations to the service point through distribution.

The aim of pharmaceutical material management is provide good quality product with the proper manner that is under the planning and organization.

Aim of Material Management

To Get- 1. The Right quality

2. Right quantity of supplies

3. At the Right time

4. At the Right place

5. For the Right cost

Introduction The prime objective of the pharmaceutical manufacturing operation

to produce finished pharmaceutical product from active, inactive raw material and various packaging material.

Vendor Selection Receiving: (Bill, Invoice, Custom Excise gate pass, COA) Quarantine Inspection: Cleaned, stacked on non wooden pallet damaged,

abnormality reported to QC. Storage: RH, RT, FIFO, FEFO, segregated properly to avoid mix-up Sampling: Coordinate with QCL Identification (Label): Status, approved, sampled rejected, Batch

NO, manufacturer’s name Dispatch: Finished good to customer, rejected material from

supplier etc. Importance: Quality material Quality finished product (R.M. P.M)

Purchasing The purchase of raw materials is an important operation

that should involve staff who have a particular and thorough knowledge of the products and suppliers.

Starting materials should be purchased only from approved suppliers and , where possible, directly from the producer.

The quality parameters should also specify characteristics like, bulk density, particle size amorphous or crystalline nature of the material, specificity of isomers.

Cont….For each consignment, the containers should be checked

for at least integrity of package and seal and for correspondence between the order, the delivery note, and the supplier’s labels.

Damage to containers and any other problem that might adversely affect the quality of a material should be recorded and reported to the quality control department and investigated.

R.M. and P.M. should only be purchased by buyer who are trained and possess sufficient technical knowledge.

Raw material Supplier of the received material should have his name listed in companies

approved vendors list. Such list should available with in receiving department.● Approved Vendor: RM is ensured that has come from approved supplier, list of vendor is available in stores

● Checking: i) Name of product ii) Batch No.

iii) MFG. Date EXP Date. iv) Quantity Received v) Condition of container vi) Name of material and supplier

After receiving of raw material should be check – i) Name of Supplier. ii) Name of the Product. iii) Batch Number. iv) Mfg. Date & Exp. Date. v) Quantity Received or No of containers or Packages. vi) Condition of Container and Material.

Cont…. All containers should be cleaned externally and damage if

any report to Q.C. department . all the received have proper document such as bills, gate passes, log book records and COA.

From the received sample material place in sampling area with proper label by Q.C person.

All received material must have identified label status e.g. i) Received Sampled.

ii) Approved. iii) Rejected.

● Material Identification like i) Product Name. ii) Batch No.iii) Code No.iv) Sterility Status.

Cont…If one delivery of material is made up of different

batches ,each must be considered as separate for sampling ,testing and release.

Material storage room should have properly labeled and have following information

Name and internal code number. Batch no given by supplier and given by receiver after

analysis and release. Status of the contents (e.g. quarantine, on test, released,

rejected, returned, recalled). Retest and expiry date of the product. Appropriate special storage condition.

Cont….

Only starting materials released by the quality control department and within their shelf-life should be used.

Starting materials should be dispensed only by designated persons.

Following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labeled containers.

Cont….Each dispensed material and its weight or

volume should be independently checked and the recorded.

All the dispensed material have proper label and record in the log book in chronological order . The record must have following points.

i) Name of the product and Batch no. for which material is dispensed. ii) Time and date of starting material and completion of dispensing activity.

iii) Name of weigher and checker.

Packaging MaterialsIt is having four types. Primary Packaging Material Material is direct contact with product e.g. Bottles, ampoules, vials, foils. Secondary Packaging Material Material which comes contact with primary product. e.g. Label, carton. Printed Packaging Materials All packaging materials which have any thing printed on it. Material like labels, cartons, foils. Tertiary and other Packaging Material All other packaging material other than those cover Primary, Secondary, Printed material. e.g. Shipper, Box.

Cont….

All the secured area like storage room having authorised access.

Maintain log book records for access.Each delivery of packaging material have

unique code or batch no.All the packaging should be checked by

packaging department.

Intermediate and Bulk Products

This are the starting material in the process but not converted to finished product.

e.g. I) Granules ready for compression. II) Compressed tablets, awaiting coating. III) Filtered or unfiltered liquid for oral injectable. Handling By : Production dept. Storage: Temp : RH class is critical. Receipt: When purchased, to be treated like RM

Finished Products

Held in quarantine until their final releaseThen stored as unable stock under suitable storage

conditionsEvaluation and documentation necessary for

release Product release procedure Batch record review and related procedure

Rejected and recovered materials

These are the materials at any stage which have been tested against set of predefined and found not meeting the specification completely.

Clearly marked Stored separately in restricted areas Action- Return to suppliers or destroyed Action approved by authorised personnel maintain

records

Cont….

Recovered materials should be exceptional cases Only if Risk involved have been evaluated and final product

will not be affected Specification are met Defined procedure Record maintain and new batch no.Such products stored in separate area in industry

painted in Red color.

Cont….

Recovered products normally between 5-10 % are added in fresh batches including any possible effects on shelf life.

The record should be maintained by authorised personnel or Q.C. department

Recalled Products

These are the product which are sold or distribute which recall after some time.

It is due to improper handling of material during process.

Stored in secure area with proper label Accessible by authorised personnel Record should be maintain Decision taken on their fate

Returned goods

These are the goods returned from market for various reasons

Q.C. department evaluates physical examinations and quality of goods received.

Decision on their fate Reprocessed Recovered Need to be destroyed

Cont….

Consider nature of products

Special storage condition

Time interval since issue

Reagent and culture media

Records for receipt or preparation Reagents Preparation according to SOP Appropriate labeling

i) Name of reagent ii) Conc (1N, 2N 20 % etc.)iii) Standardization factoriv) Shelf life / use before v) Date of re-standardizationvi) Storage condition-vii) Sign: Prepared by, Checked by

Cont….

● Culture media

Positive and negative controls should be applied

to verify stability of culture media

Waste materialsPharmaceutical manufacturing operation generate lot of

waste materialIt is of two types Trash- No resale value and disposed by proper method

depend upon nature of trash Scrap- Have resale value and maybe sold to scrap dealers1. Paper .2. Aluminium Foils. 3. Plastic. 4. Glass.5. Metallic containers.Toxic substance and flammable material storage stored at

safe area

Reference Standards

These are the official reference standards Reference standard are prepared by the

producers should be tested released and stored in the same way official standards

Stored in secure area Accessible by authorised personnel Record should be maintained It is only used for the purpose described in the

appropriate monograph

Cont….

Secondary reference standard

Appropriate label Name

Batch, lot number

Date of preparation

Shelf life

Storage condition

Miscellaneous materials

This type of materials do not falls under the category R.M/P.M

Materials like Rodenticide, insecticide, fumigating agents Sanitizing materials No contamination risk to equipment raw materials,

packaging materials, in-process materials or finish products

References

Pharmaceutical Quality Assurance by Manohar Potdar Page no-4.1- 4.18.

Quality Assurance Volume II second updated edition Page no.34 - 39

Any Question…..