Follow
1.0 Objective
To set up a guideline for archiving documents.
2.0 Scope
This SOP is applicable for archiving all documents of Quality Control laboratory of (Company Name).
3.0 Responsibility
3.1 Analyst who has completed the documents is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his nominee.
4.0 Accountability
4.1 Head of Quality
5.0 Precaution
5.1 No documents can be left-off in the QC laboratory after approval.
6.0 Procedure
6.1 Pre-requisite for archiving documents: Before archiving a document, it must be properly completed, signed and approved.
6.2 Time limit of Archive All kinds of analytical dossiers (Raw Material, Packaging Material & finished products, water, Analytical method validation etc.) must be archived within 5 working days of batch release.
6.3 Facility for archive
6.3.1 All documents shall be archived in the Archive Room which shall always be under lock and key.
6.3.2 The documents are to be achieved separately based on the types of documents (e.g.documents of Raw materials, Packaging materials, finished products of OSD & MDI, Water, Validation, stability study, Microbiology etc. to be archived in separate shelves).
6.3.3 A total of 16 shelves are designed and developed for archiving purpose. These are indicated by 1,2,..,16.
6.3.4 Shelf 1, 2, 8, 9, 15, 16 are one-sided. Rest of the 10 shelves are two-sided. These sides are indicated as A & B. Each shelf/each side contains two columns. These are indicated as C1 & C2. In each column there are five rows which are mentioned as R1, R2…, R5. Beyond this, any section can be marked in other ways based on the requirement as well as types of document.
6.4 Preparation of documents & procedure of archiving
6.4.1 Prior to archiving the documents the responsible officer shall ensure that the documents are completed and signed.
6.4.2 Each and every page of the document shall be numbered.
6.4.3 Compiled document is then stapled & punched.
6.4.4 Documents shall be carried to the archive room & kept in files or envelope.
Finished Product documents are to be kept in files and validation, optimization, Cleaning Validation, hold time study, stability documents are to be kept in letter size envelopes. Calibration reports are to be kept in data bank files. The files shall be
labeled with following information:
– Types of documents
– File no.
– Range of AR NO (e.g. Finished Product Analytical Report-File NO:1 AR NO: FP1301001 – FP1301020)
The documents kept in the envelopes shall be marked with the informations of types of documents, product name and batch no. (e.g. Validation Documents-Amdocal 5 Tablet-B#03221). Alternatively, files can be arranged according to product.
6.4.5 In archive room, a log book shall be maintained as Archive Register (Annexure-I)
6.4.6 The register shall contain the following informations-
– document / item name
– Batch no/R-No./P-No.
– AR No./Ref. No,
– File No.
– Location (containing Shelf, Column & Row)
– Archived by/date,
– Remarks.
6.4.7 Location of any document in the shelf shall be mentioned firstly by shelf no (S), then column no (C) , row no (R), section no(1/2/3).
