1.0 OBJECTIVE
To describe the procedure for assigning unique identification product codes for finished goods and common granules.
2.0 SCOPE
This code numbering system is applicable for the entire range of products manufactured at (Company Name).
3.0 RESPONSIBILITY
3.1 Head of concerned departments ...
1.0 OBJECTIVE
To confirm that the personnel performing the tests in IPQA and other documentations in Quality Assurance are adequately trained to produce reliable and accurate results within the specified parameters.
2.0 SCOPE
This procedure is applicable to IPQA officers to assure that the analysts ...
Objective To describe the procedure of batch numbering system for material milling in production facility of (Company Name).
Scope This procedure is applicable for the numbering of the material milling in the manufacturing facility of (Company Name).
Responsibility
=>> Production planning personnel.
...
1.0 OBJECTIVE
To lay down a procedure for Technology Transfer of products from one site to another site.
2.0 SCOPE
This SOP is applicable to the products to be transferred from Track-I/Sending unit to (Compnay Name).
3.0 RESPONSIBILITY
3.1 Concerned R&D/QA Head of Receiving Unit shall be responsible ...
1.0 OBJECTIVE
To laid down a procedure for raising file note.
2.0 SCOPE
This procedure is applicable for the changes made having no GMP concern.
3.0 RESPONSIBILITY
3.1 Concerned department Heads to raise/initiate and Implement.
4.0 ACCOUNTABILITY
4.1 Executive Director, Quality
5.0 PRECAUTIONS
5.1 ...
1.0 OBJECTIVE
To provide guidelines to record, check, evaluate and summarize the incidence.
2.0 SCOPE
This procedure is applicable for handling of incidence of all the systems including manufacturing and control of the products in (Company Name).
3.0 RESPONSIBILITY
3.1 Operator / supervisor shall ...
1.0 OBJECTIVE
To provide a guideline for reprocessing.
2.0 SCOPE
This procedure is applicable for reprocessing in tablet department at (Company Name).
3.0 RESPONSIBILITY
3.1 Production officer shall be responsible for recording the necessary details & to perform the activity as directed.
3.2 ...
The development and use of SOPs are an integral part of a pharmaceutical quality system as it provides individuals with the information to perform the job properly, and facilitates consistency in the quality and integrity of a product or process.
1. SOP for SOP
2. SOP for Good documentation practices
3. SOP ...
1. Objective:
To ensure continuous consistent product quality, the quality of raw and packaging material from reliable vendors is essential. The purpose of this procedure is to describe the various activities and system for the approval of vendors for the active / inactive ingredients and packaging ...
1.0 OBJECTIVE
To provide a procedure to regulate the production, installation and servicing processes, which directly affect the quality of a product.
2.0 SCOPE
This SOP shall be applicable for all personnel of Infusions Unit.
3.0 ASSOCIATED DOCUMENTS
3.1 SOP No. INFPS002 Dress Requirement and Gowning ...