1.0 OBJECTIVE
1.1 To lay down a procedure for
Analytical Reference Numbering System.
2.0 SCOPE
2.1 This procedure applies to the
Pharmaceutical Manufacturing Facility of ----------
3.0 RESPONSIBILITY
3.1 Chemists –
Quality Control
4.0 ACCOUNTABILITY
4.1 Head
– Quality Control
5.0 PROCEDURE
5.1 Analytical Reference Number (AR No.) shall be allotted for all samples entered
in quality control Laboratory for analysis.
5.2
AR
Number for Raw materials, Packaging materials, Bulk-in-process, Finished
Product, Purified water for regular
analysis and
received in quality control shall
be of six digits with a two/three alphabetical capital
letter prefix as follows.
5.2.1
In
Raw material and Packing material AR numbers are prefixed with 2 alphabetical
capital letters indicating the respective company.
5.2.2
For
Example, say Raw material received in the account of AB Limited are prefixed as
follows….
AB-----RM
5.2.3 In
case of packing materials the prefixes are given as mentioned below for
Different companies….
AB-----pM
5.2.4 The
first and second digits indicate the year, EX: 08 for the year 2008.
5.2.5 The remaining four digits are indicating the serial number, EX: 0001 is the first material of the particular year.
5.2.6 The
complete AR.No. for a Raw/Packing material
will be like this,
RM
AR.No. PM AR.No.
RM080001 PM080001
Are
the first receipt RM & PM materials.
5.3
For
the In-process bulk samples and Finished Product the AR Numbering system is
as
follows.
5.3.1
In
In-process Bulk samples AR numbers are prefixed with 3 alphabetical capital
letters indicating the respective type of in-process sample whether tablet or
capsule.
5.3.2
For
Example, say IP bulk sample received from tablet section are prefixed as
follows…. XBT. And from the Capsule section are Prefixed as….XBC.
5.3.3
In
Finished product samples AR numbers are prefixed with 3 alphabetical capital
letters indicating the respective type of in-process sample whether tablet or
Liquid syrup.
5.3.4
For
Example, say finished product sample received from tablet section are prefixed
as follows…. XFT. And from the Capsule section are prefixed as….xFC. The first and
second digits are indicates the year, EX: 08 for the year 2008.
5.3.5 The
remaining four digits are indicating the serial number, EX: 0001 is the first
material of the particular year.
5.3.6 The complete AR.No. for an IP Bulk/Finished product material for different Sections will be like this
Name of the SECTION IP BULK AR.No. FINISHED AR.No.
Tablet Section XBT080001 XFT080001
Capsule Section XBC080001 XFC080001
Are the first receipt
IP bulk & finished product samples of different
Sections like tablet
& Capsule.
5.4
For
the Purified water and wash water samples the AR numbering system is as
follows.
5.4.1 Purified
water and
5.4.2 For
Example, Purified water sample received from different locations are prefixed
as …. XPW. And for wash water received from production are prefixed as….CWW.
5.4.3 The
first and second digits are indicates the year, EX: 08 for the year 2008.
5.4.4 The remaining four digits are indicating the serial number, EX: 0001 is the first material of the particular year.
5.4.5 The
complete AR.No. for a Purified water and wash water will be like this,
PURIFIED WATER AR.No. WASH WATER AR.No.
xPW080001 XWW080001
Are the first receipt Purified water and Wash water samples.
6.0 ABBREVIATIONS
6.1 Nil.
7.0 REFERENCES
7.1 Nil.
8.0 ANNEXURES
8.1 Nil.
END OF THE DOCUMENT
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