Dear Forum Colleagues,
During the manufacturing of product ‘X’ there was deviation filed as an equipment breakdown and alternative method used in particular step which is not part of either MFR or BMR and that equipment employs the purification of product ‘X’ , other method which used directly effects on product quality and efficacy.There is no previous data is available for such deviation. After preliminary evaluation it is decided to check impact on the product against specification. Similary, product met the predetermined specification which is defined by Compendia. My query is ,
- shall the batch to be released or additional investigation shall be done on the product.
- To release the batch shall i perform the validation with simulating the conditions?
or Batch can be disposed.
Please suggest.
Thanks in advance
Dasarath
If the deviation which is affecting the quality and efficacy of the product, you can quarntine the product. Perform the process validation & if it is ok, then only release the batch.Otherwise batch shall be considered for rejection if the devation happened cant be justified considering the quality impact.
As long as I learned, still in a novice level, the deviation should be predetermined or expected under the preparation of CAPA or a certain post approval- or pre- SOP.
Then, it would be more reasonable to realease the batch. No scale down process?
[quote=rmckorea]As long as I learned, still in a novice level, the deviation should be predetermined or expected under the preparation of CAPA or a certain post approval- or pre- SOP.
Then, it would be more reasonable to realease the batch. No scale down process?[/quote]
Batch can be released to market, but root cause should be identified and necessary corrective and preventive actions shall be proposed to prior to dispatch the material to market.
Thanks and regards
I do not think that a batch that is observed for deviation should be released. It has to under go various check control procedures by Quality and compliance teams with in the organization and then check its Potency and release.
It so happens the deviated batch come back from market by a product recalls as stability becomes an issue.It does have often problems with shelf life or appearnce or some problems.
After a thorough investigation into root causes it was be released and a stability batch must be observed very keenly.
Deviation management is a major headache for FDA in third world countries. Even WHO is having such issues.
Nothing can be taken lightly as it might have its own problems with patient compliance.
A procedure is a procedure. Any deviation means, the product quality is compromised.
Hi,
In my opinion batch can be released to the market after evaluation of following
- Is the equipment used after breakdown was qualified / calibrated ?
- Is the method employed is well documented & inline with GMP ?
- Is the relevent quality tool used for recording & assessment purpose i.e. Deviation / Change Control / CAPA / OOS tec.
- Is the quality of batch meeting the spec. limits ?
- Is there any impact of change / deviation on Safety, Identity , Stability, Potency & Quality ?
- If yes, assess the relevent parameters…in this case should go with Acc. stability before releaseing the product…
Hopes it will help, Happy Reading !
[quote=rdasaratharamireddy]Dear Forum Colleagues,
During the manufacturing of product ‘X’ there was deviation filed as an equipment breakdown and alternative method used in particular step which is not part of either MFR or BMR and that equipment employs the purification of product ‘X’ , other method which used directly effects on product quality and efficacy.There is no previous data is available for such deviation. After preliminary evaluation it is decided to check impact on the product against specification. Similary, product met the predetermined specification which is defined by Compendia. My query is ,
- shall the batch to be released or additional investigation shall be done on the product.
- To release the batch shall i perform the validation with simulating the conditions?
or Batch can be disposed.
Please suggest.
Thanks in advance
Dasarath[/quote]
Let’s make it simple, this situation relates to the Reworking which is defined as Taking an out-of-spec product and running it through a non-standard process to bring it back into spec. and definitely once it deviates from the standard validated process, concurrent validation is required, that can be with limited parameters depending on the process step. The prerogative is of validation team to decide and design protocol.
Hi,
In my opinion batch can be released to the market after evaluation of following
- Is the equipment used after breakdown was qualified / calibrated ?
- Is the quality of batch meeting the spec. limits ?
The above 2 solution does not answere core problems of deviation.
The actual problem lies in Identification of Deviations and prevent its repeatability.
You need to plug the primary sources or causes.
People must be trained to Identify, Trained to handle product in a better way to prevent such deviation.
It is not so simple to release the batch based on the above 2 points.
If the quality of the batch within the trend/specification limit then batch can be released to market, but root cause should be investigated and necessary corrective and preventive actions shall be proposed if any root cause is identified prior to release the batch.
Pawan Ra!
GMP Specialist
I do agree with Mr. Durga Prasad. If we go back to the deviation, Alternative equipment/ process was used, which was not validated. Although the product is meeting the specification yet the stability is still a question. CAPA should be triggred after a through invetigation, and if needed the alternative (Deviated procedure) should be validated for future.
Once a Pharmaceutical manufacturing firm agrees to certain principles of quality manufacturing, they need to stick as per such Quality policies and procedures.
-Using alternate equipment in a standard approved manufacturing process is not allowed.The process which is not validated and using of non-qualified equipment or Equipment not fit for purpose or size of manufacturing is totally disagreed. This is a deviation if one agrees or not.
-If one manufactures the product in such conditions it should not be released. Stability is the last consideration of whole process.
This is the reason Stage 2 Process Validation as per latest FDA guidance is used to guide manufacturing companies What, Where, Why & How the equipment as well as Process should be Qualified and Verified to have a State of Control.
-It is not case of "How big that Deviation " is, but it is a case of "Why such Deviation " was carried out on a Equipment which were not qualified for the purpose?
When questions are raised by regulatory authorities you have no choice of disagreements as your batch reports completely deviate from Processing equipment.
Can alternate Process and alternate equipment be used which are not Validated & Verified?
In my opinion, deviation should be handled properly and CAPA should be initiated, finally inform to your customer about the deviation, if your customer agrees to buy your material then release the batch. Keep the records of your customer acceptance of your product.
When I see this discussion every one made their point and they are valid.
To sum this up let us divide the compliance issue here in to 2 main categories.
- A reactive compliance that is a Corrective action. This must be followed by real root cause analysis.
- A proactive compliance that is a Preventive action which helps to prevent occurrence of such Deviations such as OOT, OOS etc.
The basis of proactive compliance is a detailed evaluation study that is obtained with help of statistics, 5 why philosophy , Fish bone diagrams etc.
Usage of more than 3 tools would be beneficial.