Wednesday, March 25, 2020

What is the difference between quality control QC and Quality Assurance QA?


Quality control and Quality assurance are two terms that are frequently utilized reciprocally. Albeit comparable, there are unmistakable contrasts between the two ideas. Quality control and Quality assurance is the blend of quality assurance, the procedure or the arrangement of procedures used to measure the quality of the product, and quality control for guaranteeing products and services that meets the customer’s expectations.
Quality assurance is the process oriented and focuses around deformity avoidance, while, Quality control is product oriented and focuses around defects and distinguishing proof. Quality is extremely difficult to characterize it very well may be just expressed as “Fit or ideal for purpose or use”. It’s everything about gathering the necessities and expectations for the consumers as for function ability, structure, dependability, durability and cost of the product. While focusing Quality control and Quality assurance activities on key source categories will lead to the most significant improvements in the overall inventory estimates, it is good practice to plan to conduct at least the general procedures

Quality control and Quality assurance processes:

Quality Assurance processes
  • Plan
  • Do
  • Check
  • Act
  • CAPA
  • Risk Management
Quality control and Quality assurance are both significant aspects of managing quality, but it’s also important to point out that they are not the same thing. When used, Quality control and Quality assurance can help consistently to develop a quality of the product.
Quality control processes
  • Quality standards
  • Operational policy to deliver quality
  • Review of results
  • Get feedback

Difference between Quality control and Quality assurance

  • Plan
The organization should plan and also establish the process related objectives and determine the processes that are required to deliver a high-quality end product.
  • Do
Development and testing of processes and also “do” the necessary changes required in the process.
  • Check
Checking or monitoring of processes, and also look after whether it meets the predetermined objectives.
  • Act
Implement actions that are necessary to achieve the improvements in the processes.
  • Corrective and Preventive action (CAPA)
Medical Device organizations need to research and track quality related occasions all through everyday manufacturing activities. CAPA quality assurance gives that start from any source can be logged, while the automated workflow engine courses records through the suitable examination, root cause analysis, planning, and confirmation and adequacy steps.
  • Risk Management
Risk management processes to other quality management processes. Guarantees compliance with regulations and standards like 21 CFR Part 820. Decreases cost of quality by permitting resources to focus on the areas of highest risk.
These steps are to guarantee that processes followed in the association are assessed and enhanced on a periodic basis. An association must utilize Quality Assurance to guarantee that the product is planned and executed with right techniques. This helps reduce issues and blunders, in the final product.
Quality Control processes
  • Quality Standards
In certain enterprises, you may need to satisfy quality standards set by an outside body, for example, an industry affiliation, the local health and security examiner, or a government regulatory organization.
In others, there aren’t any official quality guidelines, so you’ll have to set your own. Every division of your business will have distinctive quality control measures. Nonetheless, they should all be objectively measurable.
  • Operational policy to deliver quality
Very much planned processes lead to excellent products and services. In the event that you make great processes, ceaselessly measure the aftereffects of the processes, and work to reliably improve the procedure, your product or service will show signs of improvement and will get better.
  • Review of results
Most business programming, from monetary and bookkeeping applications to customer relationship management the board or client service tools, lets you modify the data you gather and use dashboards to see it initially. Survey your information routinely to perceive how well your organization is satisfying its quality standards.
  • Get feedback
Utilize measureable feedback from outside sources, for example, client overviews, online evaluations and audits and net promoters scores (NPS), to get a more full image of product and service quality. Likewise, get ordinary input from workers. How well are the operational procedures attempting to deliver quality?

  • Operon Strategist helps in maintaining compliance with 21 CFR Part 210 and 21 CFR Part 211 Quality Assurance which is critical to the pharmaceutical industry. 
  • We also help in the development of training modules for comprehension to various parts of the regulations, and also in the guide in strategic review and assessment of the organization for personal optimization. 

Contact details –


Phone no -  9325283428

Mail  - dm@operonstrategist.com
If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing
    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 

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Primary Packaging Consultant For Medical Devices – Operon Strategist




Primary packaging is the term used to assign the layer of packaging in direct contact with the
product or dosage form in simple words actually, it is the first packaging layer in which the 
product is stored. Primary packaging material means any single part of a container closure 
system, for example, containers, container liners, closures, closure liners, stopper oversells, etc.
Secondary packaging material is a packaging component that is not and will not be in direct 
contact with the dosage form.

STANDARD ON PRODUCT CONTAINERS & CLOSURE
Current Good Manufacturing Practice (cGMP) requirements for the control of drug product containers 
& closures comprise in 21 CFR Part 210 & 211. Drug Master Files are a mechanism that primary
packaging manufacturers can use to share confidential information with health authorities without 
disclosing that information to the pharmaceutical industry.
In the US, Drug Master File (DMF) is a submission to the US FDA that may be used to 
provide confidential detailed information about facilities, processes or articles used in 
the manufacturing, processing, packaging & storing of one or more human drugs. 
Drug master files are a mechanism that primary packaging manufacturers can use 
to share confidential information with health authorities without disclosing that 
information to the pharmaceutical industry.

We provide Primary Packaging Turnkey Project services 

that include the following:

  • Primary Packaging Layout Design :Packaging Layout Design Is An Important Element While Setting Up A Manufacturing Unit. While Designing The Plant/Facility Layout, The Consideration Has To Be Given To The Regulatory Requirements, In Particular, The Cgmp Requirements. 
  • Clean Room conceptualization For Primary Packaging Clean Room Helps In Establishing & Maintaining An Environment With A Low Level Of Environmental Pollutants Such As Dust, Airborne Microbes, Aerosol Particles & Chemical Vapors.
  • Primary Packaging Process Validation: Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation. 

Read More  -  Primary packaging

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing
    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 



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Friday, March 20, 2020


Roles and responsibilities: QMS and the IVDR


QMS and IVDR :

One of the new key regions of obligations that should be characterized is the individual or people in charge of regulatory compliance per Article 15. In the event that more than one individual keeps up this job (to enable the maker to meet the openness necessity), the divisions of obligation should be recorded as a hard copy, for example, in sets of expectations, goals, execution-related criteria, etc. As the capability prerequisite for this job can be satisfied through either training (recognition/confirmation) or through experience, guarantee that target proof is kept up inside the records related to the person(s) named. The experience prerequisites are explicit to in vitro therapeutic gadgets, and involvement in different sorts of medicinal devices/QMS is probably going to be viewed as insufficient.
Past the job portrayal and rundown of individual duties, the maker ought to be prepared to show through records that the individual in charge of administrative consistency has in fact been acting in the normal limit. This incorporates covering the congruity of gadgets being produced and discharged, the specialized documentation and EU assertion of similarity, post-showcase reconnaissance commitments, revealing commitments and the particular classes of execution thinks about including interventional gadgets or hazard to patients. It ought not to be translated or expected that the PRRC is exploring or favouring every one of these reports his or herself, as this obligation can be designated through technique. Target proof of PRRC association can incorporate, yet isn’t constrained to, affirming systems that spread these regions, endorsing reports managing these things or investment in the executive’s surveys where these themes are secured. At long last, explicit consideration is attracted to 15(5) which expresses that the PRRC ‘will endure no detriment inside the producers association in connection to the best possible satisfaction of his or her obligations… ‘. It could be useful for this to be reflected in the pertinent sets of responsibilities or contracts.

Economic operators

Notwithstanding the individual in charge of administrative consistence, the IVDR has characterized various obligations regarding different monetary administrators (merchants, wholesalers and approved delegates). The producer needs to guarantee that these different obligations, and their oversight of them, are archived as a component of the QMS. The approved agent must acknowledge, recorded as a hard copy, the assignment of duty, and other monetary administrators will find that they have duties to confirm different parts of item consistence.

Management responsibilities

The direction additionally obviously necessitates that the administration of assets important to execute and to do the methods and approaches be characterized inside the QMS. To conform to these desires, the QMS must incorporate satisfactory arrangements to audit the designation of assets to key procedures just as the board surveys which are gone for recognizing whether a procedure is under-resourced. For instance, restorative activities which are efficiently late could be demonstrative of a deficient arrangement of assets.

Read More  -  QMS and IVDR

Contact details –


Phone no -  9325283428

Mail  - dm@operonstrategist.com
If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing
    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 

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CDSCO Import License for Medical Devices In India

  Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vi...