Skip to main content

Review on Silent Features of Quality Assurance

Quality assurance is defined as a wide ranging concept, which covers matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the objective of ensuring that the pharmaceutical products are of the quality required for their intended use.
Quality Assurance is the heart and soul of Quality Control.

Quality Assurance = Quality Control +Good Manufacturing Practice

The System of Quality Assurance:
  • Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practices (GLP) and good clinical practices (GCP).
  • Product and control operations are clearly specified in a written form and GMP requirements are adopted.
  • Managerial responsibilities are clearly specified in the job description.
  • Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
  • All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
  • The finished products is correctly processed and checked according to the defined procedures.
  • Pharmaceutical products are not sold or supplied before the authorized persons had certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products.
  • Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf-life.
  • There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
  • Deviation are reported, investigated and recorded.
  • There is a system for approving changes that may have an impact on product quality.
  • Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.

Quality Assurance - Highlights:

  • In process quality is checked during manufacturing
  • Validation of facilities, equipment's, process, products and cleaning as per master plan
  • Complaint handling
  • Storage of quality record and control samples.
  • Stability studies.
  • Registration of documents.

Activities of Quality Assurance Department:

1. Technology transfer.
2. Validation.
3. Documentation.
4. Assuring quality of products.
5. Quality improvement plans.

            1. Technology Transfer:
  • Receipt of product design documents from research center.
  • Distribution of documents received from research center.
  • Checking and approval of documents generated based on research center documents i.e. batch manufacturing record.
  • Scale-up and validation of product.

2. Validation:
  • Preparation of validation plans for facility, equipment's /process including cleaning.
  • Approval of protocol for validation of facility/equipment/product/process.
  • Team member for execution of validation of facility/equipment/product/process.

3. Documentation Control:
  • Controlled distribution and archiving of documents.
  • Control of changes made by proper change control procedure.
  • Approval of all documents.

4. Assuring Quality of Products:
  • cGMP training.
  • SOP compliance.
  • Audit of facility for compliance.
  • Line clearance.
  • In-process counter checks.
  • Critical sampling.
  • Record verification.
  • Release of batch for marketing.
  • Investigation of market complaints.

5. Quality Improvement Plans:
  • Feedback received from the compliance team.
  • Proposals for corrective and preventive actions.
  • Annual Products review.
  • Trend analysis of various quality parameters for products, environment and water.

Comments

Popular posts from this blog

Intellectual Property Rights and Portfolio Management in Pharmaceuticals

  Introduction The pharmaceutical industry depends heavily on intellectual property (IP) rights to stay innovative and competitive. Without these protections, companies risk losing the chance to profit from their discoveries. Managing a strong IP portfolio helps maximize research and development (R&D) investments, open doors to licensing deals, and keep drugs on the market longer. Still, this field faces many hurdles, including tough patent laws worldwide and changing regulations. At the same time, emerging opportunities can give companies a competitive edge if they master IP management. Understanding Intellectual Property Rights in Pharmaceuticals What Are Intellectual Property Rights? IP rights are legal tools that protect creations and ideas. In pharma, they help companies control and profit from their inventions for a certain time. Types of IP relevant to drugs include patents, trademarks, trade secrets, and data exclusivity. Each has a role in defending the company’s i...

Pharma Companies HR contact information

Dear viewers of my blog, I am happy to share the HR contact details of Pharmaceutical companies. Contact Details Of Pharma HRs : Zaydus cadila-Goa gajendravernekar@zayduscadila.com 09623458512/08326615143 Teva-Goa Maryann.Braganza@teva.co.in sanjay.pandit@teva.co.in 0832 6685538 Glenmark-Goa Vittal hebbalkar hr executivr - 9923476869 anupbannatti@glenmark-generics.com 09604151586 Watson-Goa Jyosna.bagule@watsonpharm.co.in runa.divkar@watsonpharm.co.in goa@watsonpharm.co.in 0832 6690666/777 Unichem Labs-Goa abhiram.panshikar@unichemlabs.com R&D  suraj.jadhav@unichemlabs.com vikas.parkar@unichemlabs.com Indico-Goa goahplc@Indoco.com varun.keny@indoco.com anand.ingole@Indoco.com 0832 6624109 Encube-Goa hr@encubeethicals.com nidhi.b@encubeethicals.com 8322392223 Torrent pharma-Ahmdabad mayurdesai@torrentpharma.com 9879603921/22/23/24 Emcure-pune RPKulkarni@emcure.co.in           Kishor.Mule@emcur...

An Overview of Brazil Patent litigation

  An Overview of Brazil Patent litigation Brazil plays a crucial role in Latin America's intellectual property landscape, particularly when it comes to patent litigation. The country's strong legal framework, governed by the Industrial Property Act, creates an environment where patents can be protected and enforced effectively. The Brazilian patent system serves as a vital mechanism for: Protecting innovative technologies Securing market advantages Fostering economic development Promoting technological advancement For businesses and inventors, understanding Brazil's patent litigation system is essential for success in this emerging market. The system's unique characteristics, including its bifurcated approach to handling infringement and invalidity cases, create distinct challenges and opportunities. Recent years have witnessed a surge in patent litigation cases, particularly in: Pharmaceutical sectors Technology industries Telecommunications Manufacturing This increa...