Quality review vs Statistical methods.Shewhart control chart

Dear forum,
first of all let me thank you for this site - it is really useful and helpful.
I am a quality assurance engineer from pharmaceutical company, Russia. Now we are implementing ICH Q10 principles.
And we are handicapped with quality review - this is completely new for Russia. Now we are simply analysing batch data and give the “green light” for certification and sales.
Maybe you can help me with some useful SOP or link or template of how to conduct this review.
Also there are a lot of questions with the use of Statistical methods. Should we make Shewhart control charts for all parameters? (I mean not only quality issues such as weight, assay etc but also process parameters- temperature, speed of mixer, etc?)
And how to use these data for production release?
P.S. Is it true that almost all European companies move from final quality inspection to the IPC control of parameters using the “design space”?)
Thanks in advance,


Very good & relevent question. Yes, most of companies started implementation of ICH Q-10. There are various tools which you can utilized for quality review. Here I am putting some feed for thoughts :-

  1. Objective of Review
  2. Scope of Review (What to review by whom?)
  3. Reporting methodology
  4. Timelines for review
  5. Analysis of review
  6. Solution of findings (CAPA, if applicable)
  7. Standard procedure ashouls compile all of this.

Specifically the key words they are looking for

  1. Management should have a formal process for reviewing the pharmaceutical quality system on a periodic basis.
  2. Measurement of achievement of pharmaceutical quality system objectives (No. of OOS /CAPA/Change control etc. quality tools & their finding / categorization… Internal audits) this can be quantitative or qualitative (They or looking for performance indicator so betetr to go with numaric…you can use pie chart…)
  3. Emerging regulations, guidance and quality issues that can impact the Pharmaceutical Quality System; or any business critical / innovative situation
  4. Outcome of this should be Improvements to the pharmaceutical quality system and related processes; Allocation or reallocation of resources and/or personnel training; Revisions to quality policy and quality objectives; Documentation and timely and effective communication of the results of the management review and actions, including escalation of appropriate issues to senior management.

Happy Reading !