What is pharmaceutical quality assurance?
Geneva: WHO. Key Definitions. Pharmaceutical quality assurance—Pharmaceutical quality assurance may be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient.
What is quality assurance and quality control in pharmaceutical?
Quality Assurance and Quality Control (QA, QC) is the various process management procedures employed to preserve and enhance the quality of products or services.
What is GMP in quality assurance?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
What is the role of IPQA in pharma?
Collects and inspects samples as required; inspects product for correctness, performs weight checks, torque checks, vacuum chamber tests, lot code resistance testing, collects retain samples and packages and documents as required, etc.
Which is better QC or QA?
Quality control can be defined as “part of quality management focused on fulfilling quality requirements.” While quality assurance relates to how a process is performed or how a product is made, quality control is more the inspection aspect of quality management.
What comes first QA or QC?
Quality assurance is a proactive process which starts even before the work on the deliverable has started, while quality control is a reactive process and its activity starts as soon as you start working on the deliverable.
What is the use of 7 QC tools?
The 7 QC tools are fundamental instruments to improve the process and product quality. They are used to examine the production process, identify the key issues, control fluctuations of product quality, and give solutions to avoid future defects.
What are the new 7 QC tools?
These tools, some borrowed from other disciplines and others developed specifically for quality management, include the relations diagram, the KJ method (affinity diagram), the systematic diagram, the matrix diagram, matrix data analysis, the process decision program chart (PDPC), and the arrow diagram.
What are the tools of Six Sigma?
Six Sigma Topics
- Continuous Improvement.
- Culture of Quality.
- Lean.
- Root Cause Analysis (RCA)
- Value Stream Mapping (VSM)
What is 7S quality?
7S is the new terminology consists of the seven phases namely Sort, Set in order, Shine, Standardize, Sustain or Self Discipline, Safety and Spirit. The paper explains the methodology, action steps, resources required and target outcomes for the implementation of 7S as a tool of organizing workplace scenario.
What are the 5 elements of kaizen?
The Kaizen approach consists of 5 founding elements :
- teamwork,
- personal discipline,
- improved morale,
- quality circles,
- suggestions for improvement.
What is 7S of good housekeeping?
7S of Good Housekeeping is the most basic and fundamental approach for productivity and quality improvement in all types of business. 7S of Good Housekeeping is an expanded version of 5S of Good Housekeeping. 7S stands for sort, systematize, sweep, standardize, safety, self-discipline and sustain.
What are the 5 S stands for?
5S stands for the 5 steps of this methodology: Sort, Set in Order, Shine, Standardize, Sustain. These steps involve going through everything in a space, deciding what’s necessary and what isn’t, putting things in order, cleaning, and setting up procedures for performing these tasks on a regular basis.
What are the 5 S of Lean Six Sigma?
They are sort, set, shine, standardize and sustain. Lean bases the words on the original Japanese: seiri, seiton, seiso, seiketsu and shitsuke.
What are the 5 S in a workplace?
The five in a 5S workplace organizational and housekeeping methodology refers to five steps – sort, set in order, shine, standardize and sustain. Safety should be the honorary sixth “S.”
Where can 5S be used?
The basic steps of 5S can be applied to any workplace. An office can use 5S to keep supplies organized, as can hospitals and medical clinics.
Is 5S a lean tool?
The 5S System is a lean manufacturing tool that helps to clean and organize the workplace, as well as improve how things are done through standardization. This can be accomplished with the five following steps: Sort: Remove unneeded and obsolete items from the workplace.
What are the five pillars of 5S?
There are five pillars in 5S in a continuous improvement program, which stand for: Sort, Set in Order, Shine, Standardize and Sustain — or in Japanese, Seiri, Seiton, Seiso, Seiketsu and Shitsuke.
What are the 6 S’s of lean?
It is a lean process improvement tool that stands for Sort, Set in Order (aka Straighten or Stabilize), Shine (aka Scrub or Sweep), Standardize, Sustain, Safety. 6S can be the shortened form of Six Sigma.
What is the difference between 5S and 6S?
The most obvious difference between the iPhone 5s and iPhone 6s is the size of the screen. The iPhone 5s (the little black model in the picture below) has the smaller 4-inch display while the iPhone 6s (the pink model below) has a larger 4.7-inch display.
What is the importance of 6S in a simple workplace?
6S (otherwise known as 5S + Safety) is a system that aims to promote and sustain a high level of productivity and safety throughout a workspace. While adhering to the 5S principle of Sort, Set in order, Shine, Standardize, and Sustain, the 6S method adds the concept of Safety.