Pharmaceuticals Solutions

Friday, May 6, 2022

Product Quality Review

Dhananjay vishwakarma How to prepare SOPs ,

Product Quality Review, to verify the consistency of existing process, to check the appropriateness of current specification for both starting material and finished product to highlight any trends and to identify the product and process improvements also to ensure that the review is consistent in line with technical agreement and dossier, where applicable.

Training Management

Dhananjay vishwakarma How to prepare SOPs ,

Training constitutes a basic concept in human resource development. It is concerned with developing a particular skill to a desired standard by instruction and practice. Training is a highly useful tool that can bring an employee into a position where they can do their job correctly, effectively, and conscientiously.

How to conduct process validation studies

Dhananjay vishwakarma How to prepare SOPs ,

Process Validation - Process Validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of repeatedly and reliably producing a finished product of the required quality.

Validation Protocol: A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment and decision points on what constitutes acceptable test results.

Validation Report: Document reporting the validation activities, the validation data and the summary, conclusions drawn & Recommendation.

How to correct effective GMP documents (DRF)

Dhananjay vishwakarma How to prepare SOPs ,

Document correction is correction of any documentation error in written procedure’s and records, it may be typographical errors, wrong entries, rectification or missing information etc.

How to control documents & Data

Dhananjay vishwakarma How to prepare SOPs ,

Document control over-all system of an organization or company for accessing, reviewing, revising, approving, disposition, and obsoletion of documents, data, and software. Document control plays such a major role in defining the quality standard.

Self Inspection Procedure

Dhananjay vishwakarma How to prepare SOPs ,

Self inspection procedure is verification of effective implementation of the Quality Management System in adherence to cGMP requirements including planning and to suggest corrective and preventive actions where required. This procedure is undertaking review of various approved systems and documents by appointed team members.

How to handle Market complaints

Dhananjay vishwakarma How to prepare SOPs ,

Market complaint: Any written or verbal communication, received from any customer, Govt. Agency, pharmacy, retailer, distributor, regarding the purity, safety, strength, efficacy packaging, labeling, shortage or any other issue which claims to be related to the quality of the product in the opinion of the complainer, shall be considered as market complaint.