Raw material and finished products ,Packing material specification, method of analysis and worksheets & Standard Test procedures.

Raw material and finished products Packing material specification method of analysis and worksheets & Standard Test procedures.

1.0. OBJECTIVE
1.1 To lay down a procedure for Preparation, review and revision of Specifications, method of analysis, protocols & Standard test procedures.

2.0. SCOPE
2.1 This procedure is applicable to all raw material and finished products ,Packing material specification, method of analysis and worksheets & Standard Test procedures.

3.0. RESPONSIBILITY
3.1 QC Officer or QC Executive

4.0. ACCOUNTABILITY

4.1 QC Manager

5.0. PROCEDURE
5.1. Preparation of specification, method of analysis and worksheet & standard test procedures.
5.1.1. All the Raw materials, Packing materials and finished products shall have individual code number.
5.1.2. For preparation of raw material specification and method of analysis, steps shall be followed as mentioned below.
5.1.2.1. Specification shall cover all the tests from the pharmacopoeias (IP, BP, USP). The test shall be selected on the basis of stringent limit which is common in all pharmacopoeias.
5.1.2.2. While selecting the assay, first preference shall be given to HPLC method then UV method and then titration method.
5.1.2.3. For Chromatographic purity/Related substances, all different test methods shall be covered as per IP, BP and USP pharmacopoeias.
5.1.2.4. For preparation of non pharmacopoeial raw material specification and method of analysis, vendor’ specification, vendor’s method of analysis, vendor’s certificate of analysis, international pharmacopoeia and other references viz Merck index, Remington shall be considered.
5.1.2.5. Raw material specification shall contain following details.
: PM for Packing Material
: XXX for Serial No. for STP
: YYY for revision Number.
5.1.2.6 For preparation of worksheet of raw material and finished product, steps shall be followed as mentioned
below.
5.1.2.7 Each specification, method of analysis and worksheet of raw material and finished product shall carry an unique number of 12 characters.
5.1.2.8 For raw material specification following numbering system shall be followed.
“RM/XX/YYY” where;
• RM stands for raw material specification
• XX stands for first alphabet of raw material
• YYY stands for specification serial number for each alphabet which starts from 0001 to 9999
• e.g Alpha-beta arteether’s specification number is “RMA-0001-01”
Butylated hydroxyanisole’s specification number is “RMB-0001-01”
• ZZ stands for revision number starts from 01 to 99.
5.1.2.9 For finished product specification following numbering system shall be applicable.
“FPSX-YYYY-ZZ”, where;
• FPS stands for finished product specification
• X stands for first alphabet of finished product
• YYYY stands for specification serial number for each alphabet which starts from 0001 to 9999
• ZZ stands for revision number starts from 01 to 99.
5.1.2.10 For raw material worksheet following numbering system shall be applicable.
“RM/XX/YYYYYY”, where;
• RM stands for raw material
• XX stands for year starts from 01 to 99
• YYYYYY stands for worksheet serial number which starts from 000001 to 999999

5.1.2.11 For finished product worksheet following numbering system shall be applicable. “FP/XX/YYYYYY”, where;
• FP stands for finished product
• XX stands for year starts from 01 to 99
• YYYYYY stands for worksheet serial number which starts from 000001 to 999999

5.2 .1 Review / Revision of Specification, method of analysis and worksheet & standard test procedures.
5.2.2 When there is a change in formulation like description, average weight, primary packaging material, the specification, method of analysis and worksheet shall be reviewed and revised.
5.2.3 When there is an ammendment or inclusion in pharmacopeia, specification, method of analysis and worksheet & standard test procedures shall be reviewed and revised.
5.2.4 Revised Specification, method of analysis and worksheet & standard test procedures shall have a revision number.
5.2.5 Controlled documents of specification, method of analysis and worksheets & standard test procedures shall be kept in an individual file in an alphabetically order.

6.0 ABBREVIATION