SOP for Numbering of compactor and Storage of documents in the compactor system of Documentation cell-QA
Objective : To lay down a procedure for numbering of compactor and storage of documents in the compactor.
Scope : This Standard operating procedure is applicable for formulation plant.
Responsibility :
QA Officer/Executive Doc Cell : Shall be responsible for Storage of documents and numbering of compactor system as per this SOP.
Manager- QA : Shall be responsible for compliance of this SOP.
Procedure :
Numbering procedure of compactor system :
Compactor shall be used for storage of Master SOPs, Audit reports and contract manufacturing documents, Change Control, Deviation, Non conformance records and market complaint documents, Vendor documents, Validation documents, Product masters, raw material specifications, STPs and GTPs and packaging specifications, STPs and GTPs etc.
Numbering of Compactor system shall contain 7 characters.
Compactor system has eleven block.
First character represents the block and shall be denoted as ‘B’.
Second and third character contains digits starting from 01,02,03……. and so on showing the number of compactor.
Fourth character shall be a dash. ‘-‘
Fifth character shall represents column, and is denoted by ‘C’
Sixth and Seventh character shall represents the block numbering and designated as 01,02 ,03 and so on.
For example 2nd column of 5th block shall have the number as ‘B 05- C 02’
Note:-Each Block is numbered starting from B 01- C 01 to B 10- C 15.
Storage of Documents in Compactor system
Starting from left side blocks B1 and B2 shall be used for storage of validation documents and qualification documents.
Block B3 and B4 shall be used for storage of Master SOPs, Change control, deviation, Non conformance records and market complaint documents, etc… designating one or two racks for each document as required.
Blocks B5 to B8 shall be used for storage of product masters as per there number.
Blocks B9 to B11 shall be used for storage of raw material specifications, STPs and GTPs, Packaging material specifications, STPs and GTPs.
On each block, list of stored documents in that block shall displayed for easy traceability of the documents.
Block 1 to 5 shall be used for storage of control samples. Control samples shall be stored alphabetically. Each column shall be used for a single alphabet i.e. in each column six products of same alphabet shall be stored. The designation of alphabet to column shall be done in right to left – left to right – right to left fashion.. If there are no products for a particular alphabet than instead of allotting a column, 2 racks will be left blank for that alphabet, so that in future if any product comes with that alphabet than whole shifting of control samples can be avoided. If the name of more than six alphabets start with same alphabet than starting from column adjacent to column “Z” column shall be alphabetically allotted.
Block 6 to 14 shall be used for storage of BMRs. BMRs shall be stored alphabetically. Two columns shall be used for a single alphabet and each product two racks shall be designated for each product i.e. in each column three products shall be stored. The designation of alphabet to column shall be done in right to left – left to right – right to left fashion. If there are no products for a particular alphabet than instead of allotting a column, one column shall be left blank for that particular alphabet, so that in future if any product shall come with that alphabet then whole shifting of BMRs can be avoided. If the name of more then six products alphabets start with same alphabet than starting from column adjacent to column “Z” column shall be alphabetically allotted.
Numbering procedure for Compactor II
Compactor II shall be represented as Com II
In “Compactor II” there are 11 blocks, numbered as B1, B2, B3… so on.
Each block has 3 columns numbered as C1, C2, and C3.
And each column has 5 racks numbered as R1, R2, R3, R4 and R5.
So, first rack of fourth column of eighth block in Compactor I shall be numbered as Com II-B8C4R1
Compactor II shall be used for storage of Master SOPs, Audit reports and contract manufacturing documents, Change control, deviation, Non conformance records and market complaint documents, Vendor documents, Validation documents, Product masters, raw material specifications, STPs and GTPs and packaging specifications, STPs and GTPs etc.
Starting from left side blocks B1 and B2 shall be used for storage of validation documents and qualification documents.
Block B3 and B4 shall be used for storage of Master SOPs, Change control, deviation, Non conformance records and market complaint documents, etc… designating one or two racks for each document as required.
Blocks B5 to B8 shall be used for storage of product masters as per there number.
Blocks B9 to B11 shall be used for storage of raw material specifications, STPs and GTPs, Packaging material specifications, STPs and GTPs.
On each block, list of stored documents in that block shall displayed for easy traceability of the documents.