sop for retrospective validation of process or process equipment

1. OBJECTIVE:
To implement a method of validation of process and process equipment’s already in operation.

2. RESPONSIBILITY
Production supervisor
QA supervisor



3. AUTHORITY
Production manager
QA manager
4. PROCEDURE:
1. Take five batches data for observation of the process parameter e.g. mixing in mass mixer or PLM or RMG or Blender.
2. Consider the desired function or output as checkpoints.
3. Record the data in a standard format given in annexure1.

Sr No. Date Process/ Product/ Observation Average Remark
Process equipment Batch No.
1) If the parameter under validation is having a quantitative data, record them for further study.
2) Take the average reading.
3) If individual data variation is within ±5% (feducial limit as per statistical method) of the average, the process is validated.
4) Carry out Retrospective validation once in six months / one year.
5) Checkpoints/Parameter

Process Process equipment Parameter
I. Mixing Mass Mixer Content Uniformity
II. Granulation Multi mill Granule Size
III. Tabletting Tablet m/c D.T., Av. wt, friability
IV. Coating Coating Pan D.T., Appearance, Av. wt.
V. Packing Strip/Blister Leak test, Coding