QUALITY ASSURANCE MANUFACTURING PROCEDURE

Issue Date:

RAANI CORPORATION
Document #: Title:

03/26/12

Rev.:

0
Page #:

QAP401

SOP FOR CREATION AND MAINTENANCE OF SOPS

1 of 2

REVISION HISTORY Rev 0 1.0 Initial Release PURPOSE 1.1 This procedure describes how to create and maintain appropriate SOPs for Raani Corporation. These documents are to be used as key reference tools for acceptable quality levels Description of Change Author
Q.A Representative

Effective Date 03/26/2012

2.0

SCOPE 2.1 This procedure details the basic format, revision control, authorization, and multiple characteristics that affect the end result to be attained. This procedure applies to all Quality assurance personnel who create SOPs.

3.0

EQUIPMENT AND PERSONNEL 3.1 New SOP creation and revisions can be authorized by the Q.A. or Manufacturing Departments.

4.0

PROCEDURE 4.1 Determine whether an SOP is required for the procedure using such questions as: A) Will this procedure needs to recur multiple times in the future? B) Is it appropriate to have a template for this procedure? C) Is it likely that another individual will have to reproduce this procedure in the future? D)Is this procedure important for generating a product or providing a customer service by a Core? If the answer to any of these questions is yes then it is likely that an SOP should be generated.. Take the SOP template and modify it such that the PURPOSE, SCOPE and PROCEDURE are correct for the specific procedure. The PURPOSE section 1.0 should include the specific type of procedure specified by the SOP, what is it used for, what does it generate, why is it useful, etc. The SCOPE section 2.0 should describe who would use this SOP, members of a specific Core, Administrative personnel, etc.

4.2 4.3 4.4

Prepared By: Tariq Chaudhry

Signature:

Authorized By:

Signature:

Management Representative

QUALITY ASSURANCE MANUFACTURING PROCEDURE

Issue Date:

RAANI CORPORATION
Document #: Title:

03/26/12

Rev.:

0
Page #:

QAP401
4.5

SOP FOR CREATION AND MAINTENANCE OF SOPS

2 of 2

The PROCEDURE section 4.0 should describe the procedure in sufficient detail so that it can be performed by an individual with some training in the area in which the procedure is performed, be it laboratory work or administrative functions. For lab procedures tables of reagents and how they are prepared should be included as well as detailed protocols of how to perform the specific task. Some SOPs may refer internally to other SOPs to define specific workflows. The creator(s) or modifier(s) of the SOP and the date of creation/modification should be shown at the top of the SOP. All modification dates should be maintained as a history of the SOP The SOP should be saved with a filename of the following structure: SOP x.y name.pdf where X is the SOP number 1-N numbered consecutively, y is the version number (every revision should have a revision number) and name is a one or two word description of the procedure described by the SOP (i.e.SOP2.0 SOP creation.pdf). Proposed SOPs will be approved by the management representative SOPs will be stored at secure location in the raani network and available to all Core personnel All SOPs will be authorized by the Quality Assurance Department. It will be the responsibility of the Quality Assurance Department to issue new and revised SOPs

4.6

4.7

4.8 4.9 4.10 4.11 5.0

REFERENCE DOCUMENTATION 5.1 Document all using appropriate forms

Prepared By: Tariq Chaudhry

Signature:

Authorized By:

Signature:

Management Representative