Description
SOP ON SOP
PURPOSE
To lay down a standard procedure for the preparation, approval, authorization, and control of Standard Operating Procedures.
SCOPE
This Standard Operating Procedure is applicable for the preparation, approval, control, and implementation of all Standard Operating Procedures of all departments and it is to be followed
All the SOP that will be prepared after the effective date of this SOP will be as per the current SOP on SOP. The previously made SOPs will remain the same & will be changed department-wise on a campaign basis or at the time of the next review.
REFERENCE(S) & ATTACHMENT(S)
REFERENCE(S)
WHO01.pdf.
Schedule M.
CROSS-REFERENCE DOCUMENTS
Document(s) and Data Control Procedure (
Training Program and Management.
Change Control Management
Good Document Practice (GDP)
ATTACHMENTS
ATTACHMENT
| S.No. | Attachments No. | Attachment Title | Format No. |
| 3.3.1.1 | Attachment-I | Template for SOP | |
| 3.3.1.2 | Attachment-II | Template for Attachment | |
| 3.3.1.3 | Attachment-III | Template for the master list of SOPs | |
| 3.3.1.4 | Attachment-IV | Flow chart of new SOP preparation | |
| 3.3.1.5 | Attachment-V | Flow chart of SOP Revision |
- LABEL
| 3.3.2.1 | Attachment-VI | Template for Label |
DEFINITION & ABBREVIATION(S)
1. DEFINITIONS
1.1. Standard Operating Procedure (SOP) is prepared by an authorized procedure that gives a set of instructions for a routine or repetitive activity followed by an organization. it provides operating instructions to individuals to perform a respective job properly and facilitates consistency in the quality and integrity of a product or result.
1.2. Good Manufacturing Practices: is a system for ensuring that products are consistently produced and controlled according to quality standards.
1.3. Current Good Manufacturing Practices (cGMPs): cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
1.4. Master Copy: An original document from which copies can be made for controlled and uncontrolled copy.
1.5. Controlled Copy: A controlled copy is a formal copy of the latest, correct issue (approved version) of the document; an identified issue of a document to an individual or location of the record. A controlled copy must be retrieved.
1.6. GxPs: The “x” in GxP is a variable that stands for manufacturing, clinical, laboratory, or clinical laboratory, Engineering, Warehouse, etc. GxP generally refers to GMP, GDP, GLP, and GCP regulations and guidelines established by the U.S. Food and Drug Administration (FDA).
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