Switch over to other validated equipment

(Md.Asif Hussain) #1

Dear All,
Is it acceptable to switch over the manufacturing process to other validated equipment, due to any major breakdown during half of the batch going on in one equipment and what are the quality requirements and action plan for switching?
For stage let granulation, compression, coating?


(Sunil R. Budhkar) #2

Yes, you can switch over to other qualified equipment provided following aspects are considered,

  • This is a major deviation which should be documented and investigated as per internal SOP.
  • If the other equipment is different in its working principles then it’s functioning should be carefully monitored and it’s impact on quality of the output should be well assessed and documented.
  • If the other equipment is like to like having same working principles then it’s functioning should be monitored as routine.
  • Final product quality should be closely assessed with respect to introduction of a new equipment in the process.
  • The Batch samples should be kept on stability studies to assess impact of deviationin manufacturing process.
  • Above aspects to should be recorded in the Batch Manufacturing records.

(Sajjad Ahmad) #3

if same make n model then can be shifted without any alteration in results.if different mke model and capacity then it may effect quality and properties so analysis should be conducted b4 going to nxt step.e.g if granulation in high shear is shifted to low shear it may effect grains hardness and dissolution.
if shifted from high capacity to low capacity it will be processed in 2,3 lots which may also affect results.
protocol with change in procedure will be generated and further batch will be processed on protocol not on BMR bcz BMR does not have other equipment and procedure.

(Sajjad Ahmad) #4

in case of compression a batch can be validated on more than one machines and those are part of BMR and can easily be shifted to other machinec by internal SOPs.

(Sajjad Ahmad) #5

for documentation prepare unplanned deviaton and risk assesment

(Md.Asif Hussain) #6

Dear Mr. Sunil thank you,
just i am elaborating my query,
Bullet No. 2: How to access the output?–by sampling and testing!! if suppose there is no analytical method for the intermediate step, how to proceed with?
Bullet No. 6 : How to prepare BMR or document for this part batch? what should be the batch No. for manufacturing and packing or is these lots can be mixed with the main batch?


(Md.Asif Hussain) #7

Thank you Mr.Sajjad, i agree, but
regarding the use of protocol is this acceptable to regulatory bodies, and for any critical process, let granulation, or mfg of bulk liquid how to prepare a separate protocol at the eleventh hour and its approval? and suppose product is licensor product and their approval will take time for one or two days!! what shall be done!


(Sajjad Ahmad) #8

For regulator we have deviation and according to deviation we have risk accessment and protol and sample can be put on stability

(Sunil R. Budhkar) #9

Deviations in manufacturing process due to sudden breakdown should be governed by R&D guidelines or SOP or protocol.Based on these guidelines the Batch should be processed further. R&D should design batch manufacturing record blank format for that particular step according to the guidelines or SOP or protocol. The out put from such deviated process should be carefully assessed for quality parameters as well as process parameters before proceeding for next step.In process controls should be in place.