Contents..

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 WHAT ARE RAW MATERIALS ?
 All materials that used into the manufacturing of a
finished bulk (even though it may not be present in
final product e.g. Certain solvents etc.) and which are
consumed by person using it are called as raw
materials.
 Raw materials can be either active drug or inactive
substances.
 eg. Hard gelatin capsules: even though it is used to
fill the blend of medicine, it is not considered as
package materials because it is consumed by person
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using medicines.
PURCHASE SPECIFICATION
 Definition :
 Written guidelines that precisely define the operational,
physical, and/or chemical characteristics, as well as the
quality and quantity of a particular item to be acquired.
rawmaterial.doc
 Mode of purchasing :
 By inspection
 By sample
 By description of brand
 By grading
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 Steps involved in purchase procedure:

1. Purchase requisition

2. Selection of supplies

3. Inviting Quotation

4. Placing the order

5. Receiving the material

6. Checking of invoice or bill

7. Recording of bills in books

8. Releasing the payment to the supplier

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 Staff involved in purchasing have a particular and thorough
knowledge of products and suppliers.
 Raw material can be purchased from supplier named in
relevant specification or directly from producer.
 Specification established by manufacturer for the starting
materials be discussed with suppliers.
 Pharmacist or chemist, who is familiar with quality
requirement of various material purchase department can
be head of purchase department.

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 Maintenance of stores
Storage Area Specifications :-
- Sufficient Capacity
- Clean, Dry and Maintained within acceptable temp. limit
- Designed and equipped reception area
- Ensuring of quarantine status
- Separate sampling area
- Segregation for storage of rejected, recalled or returned
material
- Safe and secure area for narcotics and highly active,
dangerous and risky material
- First in First out rule (FIFO)
- First expiring First Out (FEFO)
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  Storage conditions :-
- Room temp. Should be 30° C and R. H. 60%
- A.C storage (25± 2 ° C & R.H. 45 – 55%)
- Low temp. storage 2 – 8 ° C
- Separate area for Sterile product storage in A.C
- Light sensitive material in amber color container
- Hermitically sealed container
Labeling of material in storage area
- Designated name of product and internal code reference
- Batch no. given by supplier
- Status of Content
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- Expiry date or date beyond which retesting is necessary
  During fully computerized system used, labeling with all
above information need not be necessary
 Check list before storage
- Integrity of package and seal
- Correspondence note for the order, delivery and suppliers
labels
 Check list during storage
-separation of rejected, recalled, quarantine, on test,
packaging materials.
-quality of materials
Released by q.c. dept. only
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  Selection of Vendors
 Purpose :-
It is designed to evaluate suppliers and
manufacturers with an implementation scheme to assure
regulatory compliance.
A system which assures that a supplier’s product is
produced under controlled conditions, resulting in
consistent quality conformance.
Require fully involvement and agreement of both partners.
Vendor is classified by the finished dosage form
manufacturer relative to its credibility .

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  Determine the selling price of the API from the vendor,
i.e. the cost to the finished dosage form manufacturer. This
information is needed for a profitability evaluation of the
finished pharmaceutical product
 Begin the actual process of vendor qualification –
evaluation of sample of API .
 The finished dosage form manufacturer should conduct a
vendor audit.
 Followings are too considered…
 Response to the quotations invited.
 The price is lowest or reasonable as compared to the
competitors.
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 His general behavior and attitude when
the raw materials are returned by the purchaser
and his reputation in the market.
 SOP and Record of Vendor
Certification
- Selection of Material based on ABC
analysis
- Selection of Vendor for above selected
material
1. Past history of supplies made by him
2. Trend of quality of material
3. Commitment to quality and delivery
dates
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4. Compliance of quality parameters
 - Following process components should be studied with supplier
or manufactures
1. Study of suppliers mfg. process
2. Product specification and evaluation
3. Process evaluation
4. Process and specification changes & change control system
compliance
- Carried out and represent Formal technical audit report of
vendor.
- Based on audit finding vendor can be certified or decertified.

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  Steps involved in vendor certification process
 Selection of customer team : to define the objectives
& the potential benefits.
 Supplier selection .
 Initial supplier contacts.
 Process elements: 1. supplier process.
2. specification
3. process evaluation
 Process and specification changes.
 Customer specification.
 Supplier reporting : 1. certificate of compliance from
supplier
2. feedback form to supplier.
Decertification : lesser status of “ approved” or “ preferred”
 Adv. of certification process: - the tighter specification range.

- reducing testing by customer .

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- cost reduction
  SOP on receipt , storage ,sampling of materials.
A. Receipt of materials:
i. Visual examination for all incoming materials
 Intact container, lid, seals
 Evidence of any physical damage to the containers
 Evidence of rodent or insect specification.
 Proper labeling in specified manner
ii. Points to be checked & recorded
 Date of receipt
 Name of product, batch no., control no. assigned by
manufacturer.
 Quantity received against document
 Name of supplier
 Purchase order no.
15  Excise gate pass etc.
 B. Storage of materials:
i. External cleaning of container after receiving &before
storage
ii. Quantity verification
iii. Storage in specified area as per condition
 R.T./ A.C./ Cool /cold/ low humidity area.
iv. Storage as per quarantine status of the material
 received, sampled, approved, rejected .
C. Sampling of materials:
i. Sampling responsibility
ii. Sampling formula used
iii. Method of sampling e.g. top, middle, bottom sample is
required
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 i. Material wise quantity to be sampled as per requirement
of analysis.
ii. Sampling room specification:
 Temp.
 Relative humidity
 Air pressure
iii. Specific requirement for specialized product:
 Sterile products
 Poisons or potent drugs
 Beta lactum products
 Sex hormones
 Steroids
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 iv. Opening and closing of containers before & after
sampling.
v. dress code of people doing sampling
vi. Cleaning, drying, sanitization of utensils used for
sampling.
vii. Identification of sampled containers
viii. Sampled containers and sample collection containers
should have following details :
 Name of materials & manufacturer
 Batch no. for manufacturer
 Date of sampling
 Name & sign. Of sampler etc.
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 CONTROL ON RAW MATERIALS:
Quality assurance should make periodic sanitation and
follow up to assure that deficiencies are corrected.
Raw materials with abnormally high microbial
contamination may have to be subjected to a sterilization
procedure like heat treatment, radiation or crystallization
from a bactericidal solvent like alcohol.
Warehouses are the first operational area observed by the
auditor to check operational compliance with cGMP & FDA
regulation.
 Following elements need to be considered when
establishing warehouses operation:
cleanliness , floors , lighting & SOPs .
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 Finished Products
 A product in the marketable pack
 Practically a transportable pack
 E.g. shipper containing salable material
 SOP for controlling (transfer, storage) of finished
products.
 Transferring of finished packs from transportable packs to
finished goods warehouse with finished goods transfer note
giving batch no., quantity, date, time, etc.
 Collect and analyze the samples specification against using
validated test methods.
 part of sample kept as retained material for it SOP.
 List of products should be provided to finished goods store.
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 Indian Pharmaceuticals Limited
Full scale calibration of weighing balance.
Balance code:--------- ref SOP no: ------------
Weighing m/c no: ------- Capacity Min: ---------
Location no : --------- Capacity Max : -------
Calibration no : ------ Month : -----------
Valid up to : ---------- Frequency : ---------
Usage capacity : Min. ------ Next calibration due on : --------
Max. --------

Sr no Calibration Calibrated Observed deviation Calibrated Checked

date for wt for wt. by by

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 Indian Pharmaceuticals Limited
List of standard weights
Sr no. weights Date of Validity of Remarks
calibration collection in any
1 1.0 kg.
2 0.2 kg.
3 0.5 kg.
4 2.0 kg.
5 5.0 kg.
6 Etc.
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 Indian pharmaceutical limited
Balance cleaning record.
Date Type of Code Time of Cleaned Checked
balance no. of cleaning by by
balance
From To

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 Indian pharmaceutical limited
Daily gross check of balance

Location : Ref . SOP no:

Type of balance : Model no:
Code No. : Capacity: min :---- max: ----
Month :
Date Zero remark sign date Zero remark sign
checked checked s
by by

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 Indian Pharmaceuticals Limited
Raw material receiving observation sheet
Sr. Mat Synonymous Date of Name of Qual Invo
no. eria Name/brand receipt Manufactu ity ice
l name rer supplier recei No.
Na pt &
me Date
1.

2.

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 Indian Pharmaceuticals Limited
Raw material sampling observation sheet
Ref. SOP. No.
Name of Materials
Claimed grade (IP/BP/USP)

Import or mfg. LIC. no

Name and address of manufacturer

Name of packer or trader if any

Inner lining of bags

Checked against specification no.

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Sr Batch Quantity M Exp. No of packs Sample Container
no No f sampled qty. No.
d Sampled
.

Qty. Per No. Total

Pack of Qty.
pack

Sr. No. Batch no. No. Pack Damaged Type of Damaged Remarks

Observation during Sampling :

Form: __________ Color: ________________
Odor: __________ Foreign matter: __________
Spillage if any: _______
Sampled by: Name: _________ Date:_____
27 Sample Handed: A Ref No. ________________
Over to: __________
 Daily stores Inward Reports of R.M
Date:
Sr. No. Name of Items Quantity on Challan Name of Party

Temperature and Relative Humidity Record

Department Month
Area Prescribed Range
(a)For Temp °C
(b)For % RH
Room No. Ref. SOP. No.

Date Time Dry bulb Wet bulb % RH Initials of Remarks

temp °C temp °C Officers

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 References

 CGMP for Pharmaceuticals by Manohar A. Potdar

 GMP for Pharmaceuticals , Fifth edition , by Sidney H. Willing.
 Pharmaceutical Industrial Management by G.Vidyasagar.
 gmp-quality.com

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