Sanjay N. on LinkedIn: #qualitymatters #gmp #gdp #pharmaceutical #biotechnology… | 21 comments (2024)

Chris Martin - Christa GDP Pharma Ltd

GDP Expert - Qualified RP & RPi - Trainer - Auditor - Quality specialist

10h

At the end of the day, it is true that regulators have broadly moved away from using 'planned deviation' and instead they now recommend using terms like 'temporary change' or 'short-term change' to avoid confusion with unplanned deviations, so it is the preferred terminology now to describe what used to be called a 'planned deviation'. I agree that a deviation that was planned beforehand is effectively a change, whereas a deviation is effectively unplanned, so the change of terminology is logical.It's probably one of the terms that is most contentious in our world of quality, because it used to be widely accepted but modern practice has pushed the term aside, for good reason in many ways, but the old guard (of which I am one 😉) still see the term with some kind of nostalgic affection LOL.Anyway, it's use still causes a debate and it's a debate I still like to have (as you can see). Great post again though Sanjay N.

Bharathi Kodali

Regulatory strategy and Intelligence/CMC Expert/QMS Expert

5h

Instead of planned deviation, we can try with "interim change control". This involves a structured, documented process for managing unexpected changes or circ*mstances that necessitate deviation from established procedures.Advantages for this approach:1) Risk/Benefit Analysis2) Accountability and transparency, leaving a clear audit trail for future reference and analysis.3) Continuous Improvement

Antonio Greenlee(He/Him/His), MBA, CSSBB

Site Operations Lead | Quality Assurance | Pharmaceutical Manufacturing | Strategic Planning | Operational Excellence | Process Improvement | cGMP Compliance

6h

Thank you for your valuable insights, Sanjay N.!

Lee Anderson

Group Product Quality Manager at Owen Mumford

2m

If you are planning to deviate, you are in control, if you don't plan, you are non conforming.

Avasar Pharma

11h

Absolutely right. Temporary CC process is the best approach to avoid diluting the tested and approved process or procedure.

Mandy Muscat

Quality Management Systems Manager | QP | MBA

4h

There is no difference in principle between planned deviation and temporary change control. Based on past experience using temporary change controls, the system got abused. Now, while building a new QMS, I adopted the process of planned deviations after discussing with other colleagues including QPS with experience. Even the term deviation raises an alarm that this is something against the process, so it automatically triggers the requestor to think of a solution for it not to happen again, and it can also lead to a CAPA. Through the planned deviation, while investigating one might realise that the process needs an update, and one does not have to wait for repetitive temporary change requests. It's a matter of approach, not that any of them is wrong or right.

Jehanzeb Zafar

IT Leadership / Compliance Regulatory governance / Project and Program Management / Lean Six Sigma CI and PI

4h

FDA agrees to planned deviation of it is document and it happened before. It is not the best way but it is agreed way. This picture is not a very good dipiction of planned deviation , it has some level of risk based approach to it. You only approve planned deviation if the risk ia low not when the whole plan is going to go down :).

Anthony Debono

Head of Research & Development API at Medichem

5h

It’s just a matter of terminology. Provided the review and approval process is the same and provided risk to quality is managed adequately, what difference does it make whether it is an interim change or emergency change control or a planned deviation?

Chaitanya Baliga

5h

Planned Deviation is unplanned Change Control depending on the situation and scope!!! food for thought.... 🙂 Should consider risk based approach to drive temporary/interim/short term change control for specific period.

Chris Martin - Christa GDP Pharma Ltd

GDP Expert - Qualified RP & RPi - Trainer - Auditor - Quality specialist

11h

Sanjay N. Ahh, this old argument again! To me, it is just the term 'planned deviation' that causes angst amongst quality professionals - rather than the actual process being followed itself. I recently wrote a couple of posts about this very topic and it did spark a debate for sure!However, as I pointed out before, The 'MHRA's Guidance for Specials Manufacturers' (Revision 2 - January 2021) - updated 25th February 2021, still states in section 3.1.3, under the heading of 'Capacity Planning', the following passage: "A unit’s defined capacity should only be exceeded infrequently. If it is exceeded, approval from QA must be sought through the use of the planned deviation system."Yes! It says "through the use of the PLANNED DEVIATION system"! The document is still available on GOV.UKwebsite an it is still the latest guidance available there - the link is here:https://assets.publishing.service.gov.uk/media/603526f28fa8f54330a8e25f/QA_Version_3_-_Aseptic_manip_updates.pdfWith so much ambiguous information being supplied by competent authorities about what terminology to use, it's no wonder the term 'planned deviation' still gets used in conjunction with 'temporary change' and vice versa.