PHARMACEUTICAL RAW MATERIAL.pdf

PHARMACEUTICAL QUALITY ASSURANCE.
B.PHARM (VI-SEMESTER).

1. PHARMACEUTICAL
RAW MATERIAL
BY
BALASUNDARESAN M

2. Contents..

PURCHASE SPECIFICATION

MAINTENANCE OF STORES

SELECTION OFVENDORS

CONTROL ON RAW MATERIALS
AND FINISHED DOSAGE FORM.

RAW
MATERIAL

3. 9 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

using medicines.
MES

4. ÜPURCHASE 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

y sample

y description of brand

y grading

5. OsSteps involved in purchase procedure:

|. 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

6. 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.

7. 7

总

口 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)

MBS

8. E

8

Ke

® 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 “q
- 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

- Expiry date or date beyond which retesting is necessary
MBS ? + 78

9. ~

e 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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10. Y

U 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 .

11. ~

® 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,

© -
NS

12. 7 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

13. A

- 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.

14. 2

ㅁ 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,
à 14
- cost reduction

15. SOP on receipt , storage sampling of materials.

Receipt of materials:

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

Points to be checked & recorded

Date of receipt

Name of product, batch no., control no. assigned
manufacturer.

Quantity received against document

Name of supplier

Purchase order no.

es Excise gate pass etc.

16. Storage of materials:

External cleaning of container after receiving &before
storage

Quantity verification

Storage in specified area as per condition
R.T./ A.C./ Cool /cold/ low humidity area.
Storage as per quarantine status of the material

received, sampled, approved, rejected .

Sampling of materials:

Sampling responsibility
Sampling formula used

Method of sampling e.g. top, middle, bottom sample is

required

N

17. Material wise quantity to be sampled as per requirement

of analysis.

Sa mpling room specification:

Temp.

Relative humidity

Air pressure

Specific requirement for specialized product:
Sterile products

Poisons or potent drugs

Beta lactum products

Sex hormones

Steroids

>

18. NX

Opening and closing of containers before & after
sampling.

dress code of people doing sampling

Cleaning, drying, sanitization of utensils used for
sampling.

Identification of sampled containers

Sampled containers and sample collection containers
should have following details :

Name of materials & manufacturer

Batch no. for manufacturer

Date of sampling

”ws Name & sign. Of sampler ete,

19. CONTROL ON RAW MATERIALS:

2 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 cı ' stallization

from a bactericidal solvent like alcohol.

® Warchouses 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 .

20. Finished Products

er product in the marketable pack

e Practically a transportable pack

e E.g. shipper containing salable material

D SOP for controlling (transfer, storage) of finished
products.

e Transferring of finished packs from transportable packs to

finished goods warchouse 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 storg.

21. Indian Pharmaceuticals Limited
Full scale calibration of weighing balance.

Balance code: ref SOP no:

Weighing m/c no: -一 -一 Capacity Min:

Location no: Capacity Max :

Calibration no : 一 一 Month :

Valid up to : Frequency : —

Usage capacity : Min. 一 一 Next calibration due on :
Max. -一 -一

Srno Calibration Calibrated Observed deviation Calibrated Checked
date for wt for wt by by

22. On aun fF WN ea

Indian Pharmaceuticals Limited
List of standard weights

weights Date of Validity of
calibration collection

1.0 kg.
0.2 kg.
0.5 kg.
2.0 kg.
5.0 kg.
Etc.

Remarks
in any

23. Indian pharmaceutical limited

Balance cleaning record.

Typeof Code Time of Cleaned Checked
balance no.of cleaning by by
balance

Fron} To

24. Indian pharmaceutical limited
Daily gross check of balance

Location :

Type of balance :
Code No. :

Month :

Date Zero remark sign
checked
by

Ref. SOP no:
Model no:
Capacity: min :---- max: ----

Zero remark sign
checked s
by

25. ion

Tia Te 0,00 vation sheet

Synonymous Date of Name of
Name/brand receipt Manufactu
name rer supplier

26. Name of Material:

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.

27. Quantity ). N k Sample Container
No.

Sampled

No. Total

of Qty.
pack

Observation during Sampling :

Form: Color:

Odor: Foreign matter:

Spillage if any:

Sampled by: Name: Date:__
Samplg.Handed: ARef No.

Over to:

28. Daily stores Inward Reports of R.M

Date:

Chall

Temperature and Relative Humidity Record

Prescribed Range
(a)For Temp °C
(b)For % RH

Ref. SOP. No,

29. References

Y CGMP for Pharmaceuticals by Manohar A. Potdar
Y GMP for Pharmaceuticals , Fifth edition , by Sidney H. Willing.
Y Pharmaceutical Industrial Management by G. Vidyasagar.

Y gmp -qua lity ‚com

30. THANK VOU
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