QA & QC

SOP on New Product Design and Development Process

Objective :To lay down a Procedure for New Product Design and Development Process. Scope :This Standard Operating Procedure is applicable all pharmaceutical formulation plants of Pharmaceutical Company. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data for DCGI permission. …

Read More »

SOP On In-process Control of Packing Line

OBJECTIVE :To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE:This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY : In process Quality Assurance Officer / Executive shall be responsible for follow the procedure mentioned in this SOP …

Read More »

SOP on Sampling of Intermediates and Finished Products

OBJECTIVE :To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE:This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY: In process Quality Assurance Executive/Officer shall be responsible for follow the procedure mentioned in the SOP. ACCOUNTABILITY:Head Quality Assurance shall be accountable …

Read More »

SOP On In-process Control During tablets Manufacturing

SOP On In-process Control During Tablets Manufacturing OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE :This SOP shall be applicable for in process controls during tablets manufacturing of pharmaceutical company. RESPONSIBILITY:Production /Quality Assurance Executive/Officer shall Be responsible for follow the procedure mentioned in this SOP. …

Read More »

SOP on Line Clearances

SOP on Line Clearances  OBJECTIVE :To ensure that the area and equipment, required for the manufacturing and packing activities of pharmaceutical products are free from any potential sources of cross contamination/ mix-ups. SCOPE:The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities. Responsibility: Officer/ …

Read More »

SOP on Handling of Primary Standard

Objective:To lay down a procedure for the handling of Primary Standard. Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Pharmaceutical Company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall be accountable for implementation of …

Read More »

SOP on stability study of volumetric solution

Objective:To lay down a procedure for Carrying out stability studies of volumetric solutions Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at pharmaceutical company name with location Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall be accountable for …

Read More »

SOP on Good Laboratory Practices (GLP)

SOP on Good Laboratory Practices (GLP)   Objective:To lay down a procedure for operation of “Hot Plate”. Scope: This Standard Operating Procedure is applicable to Quality Control Department followed at pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head …

Read More »

SOP on Analyst Qualification in quality control

Objective:To lay down a procedure for Qualification of Analyst working in the QC laboratory Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Name of Pharmaceutical company with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall …

Read More »

SOP on handling of Out of trend (OOT)

Objective:To lay down a procedure for handling of Out of trend for stability sample Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head …

Read More »
error: Content is protected !!