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SOP On SOP

SOP ON SOP

Original price was: ₹300.00.Current price is: ₹200.00.

SOP ON SOP -Premade documents in Microsoft Word

  • SOP ON SOP
  • Attachment-I – Template for SOP
  • Attachment-II – Template for Attachment
  • Attachment-III -Template for master list of SOPs
  • Attachment-IV – Flow chart of new SOP preparation
  • Attachment-V -Flow chart of SOP Revision

Creating SOPs in a pharmaceutical project requires a significant amount of time, effort, and human resources. Months are dedicated to the creation and review of documents, yet they often remain incomplete. Our pre-made documents offer a solution by saves both time and manpower. They enable the timely initiation of production, which is advantageous for your company. In the business world, time is equivalent to money.

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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.
3.3.1.1Attachment-ITemplate for SOP
3.3.1.2Attachment-IITemplate for Attachment
3.3.1.3Attachment-IIITemplate for the master list of SOPs
3.3.1.4Attachment-IVFlow chart of new SOP preparation
3.3.1.5Attachment-VFlow chart of SOP Revision
  • LABEL
3.3.2.1Attachment-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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