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The retention period for the Documents and Records in which record shall be retained /preserved in a facility according to their archival policy. The followings are the records and their recommended archival period. Record Retention and Archival Policy  in Pharmaceuticals 1.0    POLICY DOCUMENTS Sr. No. Document / Record Name Record Retention Period / Archival […]

A document is a physical or digital representation of a body of information designed with the capacity (and usually intent) to communicate. Below the Standard Operating System (SOP) for Document Management System. A document may manifest symbolic, diagrammatic or sensory-representational information. Following are some examples, but not limited to. SOP for Document Management System 1.0  […]

Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which establishes scientific evidence and provides a high degree of assurance that a process is capable of consistently yield products meeting pre-determined specifications and quality attributes. SOP and Protocol for Process Validation of Drug Product 1.0  […]

Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging, and analytical details. SOP on Technology Transfer of Drug Product 1.0      PURPOSE: […]

Standard Operating procedure (SOP) for rounding off figures, numbers of analytical test results, including assay result rounding off, related substances (RS) result and other laboratory generated quantitative value and their reporting system. SOP for Rounding Off Test Results 1.0      PURPOSE: The purpose of this SOP is to describe    the    standard for “Rounding off” […]

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) 1.0   PURPOSE: To lay down the […]

Reduce Testing in Raw Material Standard Operating Procedure  (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity of Quality Control for speedy release of RM. 1.0     PURPOSE: The purpose of this SOP is to describe the procedure for  reduce testing in analysis of raw materials.. 2.0  […]

Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system in which the product is marketed. It may Starting Material, Packaging Material, Drug Substance or Finished Drug Product which is stored to evaluate the potential risk during self life of the batch. Sample should be […]

The Development of hand-held Raman Spectrometers has drastically changed the manner of internal control for incoming raw material. Raman has provided advantages over alternative ways in this. It doesn’t need sample pre-treatment or direct contact with the sample, and has the unique capability of having the ability to check a sample directly through a clear wadding like glass or plastic. With the additional benefit of portability, hand-held Raman spectrometers significantly increase potency/productivity by eliminating […]

Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments needs to be established to ensure that it is capable of consistently achieving desired level of cleanliness. To ensure the state of cleaning Hold time Study is required. This validation study to be executed for […]

Internal Audit (Self Inspection) checklist for various departments of Pharmaceuticals like Quality Control, Quality Assurance, Production, HR and EHS etc. Below Internal Audit (Self Inspection) checklist being used for the assessment of respective departments . these are the minimum requirement for the compliance. It would be the agenda of Internal Audit (Self Inspection) checklist. Copy […]

In the SOP on Internal Audit and Self Inspection, describe the detailed procedure to carryout the the Self inspection and Internal Audit in various department of pharmaceuticals. Audit is a systemic and independent examination to determine the quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are […]