Auditing in Solid Oral Dosage Form Production Department

1
A SEMINAR ON
AUDITING IN SOLID ORAL DOSAGE FORM
PRODUCTION DEPARTMENT
(TABLET & CAPSULE)
Prepared by-
SANJAY KUMAR PUROHIT
2nd Sem M.Pharm PQA
Graduate School of Pharmacy
Guided by-
Mr RAVISINH SOLANKI
Assistant Professor
Graduate School of Pharmacy
Academic Year 2020-21

Content
Basics of Audit
Tablet
Capsule
Point to Keep in Consideration while Auditing
Check-list Format
Data Reviewed
Document Reviewed
References
2

Outcome
To understand the basic and types of Audit.
To understand Quality Audit system in Pharmaceutical Solid Oral Production
department.
To explain the Basic format for Audit Checklist.
To Prepare the Audit Checklist.
The understand point to Keep in Consideration While Auditing Solid Oral Dosage
Form Production Department.
3

Audit
Audit defined as a systematic and independent examination to determine
whether quality activities and related results comply with established policies,
and operation procedures and recommend necessary change in control, policies
and procedures.
4
Types of Audit
Internal Audit
External
Audit
Regulatory
Audit

The key elements of Audit are
It should be systematic.
It should conducted by someone independent of the
operations.
The audit should be documented.
The audit findings should be evidenced based.
 The auditor should evaluates the findings.
The auditor should makes a decision regarding the extent
that the audit criteria have been fulfilled.
5

Tablet
Tablets are solid dosage forms usually obtained by single or multiple
compression of powders or granules. In certain cases tablets may be
obtained by moulding techniques. They are uncoated or coated.
6
Figure – 1 Tablets of Different Shape

Flow Chart of Tablet Production
7

Capsule
Capsules are unit solid dosage forms in which the drug substance is
enclosed in either a hard or soft soluble shell of a suitable form of
gelatin.
8
Capsule Types
Hard Gelatine Capsule Soft Gelatine Capsule

Dipping in
Gelatine
Solution
Setting and
Drying
Stripping
Cutting and
joining
Finished
product
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Encapsulation
Preshaping
and washing
Drying and
Inspection
Printing and
Packaging
Finished
Product
1. Capsule Shell Preparation
2. Finished Product Capsule Preparation

General Consideration for Solid Oral Dosage Form
While Auditing
Whether the unit has provide effective air extraction systems with
discharge points to avoid contamination of other products and process
Filters to be installed to retain dust.
Whether the unit has taken precaution to avoid contamination of fibre
shedding materials like wood.
The unit is monitoring environmental conditions of pressure differential
between rooms.
Temperature and humidity is controlled while processing of aspirin ,
ferrous sulphate ,tablets etc.
Whether metal detector provided.
10

Audit Checklist
Edition no.:
Effective Date:
Department:
Approved:
Dry Production: Tablet, Capsule
11
Audit Checklist
Date of Audit :
Product Name :
Manufacturer :
Purpose of Audit : Routine/Other
Specify :

Documents Reviewed:
1. SOP
2. Personnel
Data Reviewed:
1.Facilities
2.Prevention of cross –contamination
3.Equipment and facility cleaning
4.Working Procedures
5.In-processcontrol
6.Lubricants
7. Equipment Qualification
12

Conclusion
Based on the review of above mentioned document and data in accordance with
the information recorded on following pages the department has been audited for
compliance with company SOPs and cGMP.
Corrective action is – required/not required
If required then specify
Audited by:- Name
Department
Date
13

SOP Review
Sr.no. SOPs Yes No Comment
1 Is a complete index and complete set of applicable
SOPs available in the department
1.1 Are the index and SOPs current
1.2 Is the set of SOPs correctly organized according to
the index
14

Personnel Review
15
Sr.
No
Personnel Review Yes No Comment
1 Select three employees working in the department. Are their training records
up-to-date.
2 Have the employees undergone training in the following area during the last
year.
1. GMP
2. SOP
3. Tableting and capsule technique
3 Question several employs about the operation they are performing. Are they
have knowledge about function.
4 Have the employ undergone qualification according to relevant SOPs
5 Are the employ attired according to garmenting SOPs
1.When necessary do operators wears mask and gloves
2. Are beard covers used.

Facilities Review
.
16
Sr.no. Facilities Yes No Comment
1 Is the department maintained in a good state
of repair
2 Is the department neat and orderly with
sufficient space for equipment and operation.
3 Are all work areas clearly labelled with the
name and the batch number of the product
being processed.
4 Are the all work clearly labelled

Prevention of Cross-contamination Review
17
Sr.no. Prevention of Cross-contamination Review Yes No Comment
1 The doors closed at all time.
2 Is personnel clothing clean , unstained and dust free
including shoes.
3 Is there a shoe-cleaning device in the department.
4 Is there a record of the pressure.
5 Are there approved facilities for maintainance of ceiling
filters

Equipment and Facility cleaning Review
.
18
Sr.no Equipment and Facility cleaning Review Yes No Comment
1 The pallets and drums brought into the area clean and free
from powder or dust.
2 Is the equipment neat clean and rust free
3 Are there specific procedures for the cleaning of machines
4 Is equipment is suitably design for its purpose

5 Is equipment is constructed so that product surfaces are not reactive
or not absorvtive
6 Are there any specific procedure for cleaning of machines
7 Select one batch record on machine duty card
8 Visually check the machine which not in use and inspect is it clean
properly
9 Do cleaning procedure specify the detergent type and concentration
to use
10 Is there approved protocol cleaning validation of machine
11 Is there air suction tubing used in department to prevent powder
dispersion
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Working Procedures
Sr.no Working Procedures Yes No Comment
1 Examine the record of daily check of balance in Department
2 Perform a visual examination of weight with which the check
is performed
3 Examine the batch record and the batch is being processed
4 Is the suction system working during functioning
5 Do yield calculation after conform with relevant SOP
6 Is there SOP for receipt of punches and dies in the
department
7 Is there formal program for tablet tooling maintainence ,
including regrinding or repolishing
20

In-Process Control Review
21
Sr.no. In Process Control Review Yes No Comment
1 Is there an approved SOP for in-process control
2 Do all test result conform to specification
3 Are there printouts available for all in-process test result
labelled
1. Product name
2. batch number
3.Date and time of testing
4. Signature of the tester
4 Examine a running batch sheet and check all the test
specification.
5 Is there a SOP for collecting a composite sample for final
testing by quality control

Lubricants
Sr.no. Lubricants Yes No Comment
1 Is equipment design in such a way that lubricants or
coolants can come into contact with component or drug
product
2 Is there approve list of food grade lubricants for use where
they may contact product
A. Is there written procedure for the receipt and approvel of
such lubricants.
B. Is the record made for catalog number of the lubricant
used when maintainance is performed.
3 Examine the lubricant available in the department are they
clearly labelled in sanitry manner
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Equipment Qualification
Sr.No. Equipment Qualification Yes No Comment
1 Is there approved qualification programme of all
tableting/capsule equipment
2 Select one tableting machine and examine the IQ/OQ
protocol
A. Is machine is identified with a distinguish code number
B. Is all the instrument is identified with valid calibration
sticker
C. Physically verify all instrument found on the machine
including protocols
D. Crosscheck with the calibration record
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List of Equipment is used in Tablet Section
Sr.no. Equipment Name Make Model Machine Number Total Area
1 Mass Mixer
2 Drum Mixer
3 Rotary tablet machine
4 Multi-mill
5 Sifter
6 Tablet Disintegration
Machine
7 Fluidized bed dryer
8 Friabilator
9 Coating Pan
10 Polishing pan
24

25
Sr.no. Equipment Name Make Model Machine
Number
Total Area
11 Sifter
12 Counter Pan
13 Dehumidifier
14 Physical balance
15 Single Pan Balance
16 Hardness tester
17 Deduster Machine
18 Tablet inspection belt
19 Air handling unit
20 Blister Packaging Machine

List of Equipment used in Capsule Section
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Sr.no. Equipment Name Make
Model
Machine
Number
Total Area
1 Sifter
2 Rota Cube
3 Capsule filling machine
4 Dehumidifier
5 Automatic capsule loading machine
6 Counter pan
7 Physical balance
8 Semi automatic capsule filling machine
9 Capsule polishing machine
10 Air handling unit

References
• Karen Ginsbury, Gil Bismuth ;Compliance Auditing for Manufacturers – A Practical
Guide to In-Depth System Auditing ; Interpharm CRC Press.
• Herbert A. Lieberman, Leon Lachman; Pharmaceutical Dosage Form-Tablet;
Volume -2; Second Edition; CBS Publication & Distributors.
• Herbert A. Lieberman, Leon Lachman; Pharmaceutical Dosage Form- Capsule;
Volume -2; Second Edition ; CBS Publication & Distributors.
27

Auditing in Solid Oral Dosage Form Production Department

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