Critical Parameters for Retrospective Validation

GOOD VALIDATION PRACTICE (cGVP)
1

Dear All,

1.Can anyone mention what are the critical parameters that are to be considered when performing the Retrospective Valdiation of Tablets, Liquids, Gels and Suspension? If so, can u please provide me the reference / guideline?

  1. What are Definitions of Critical Processes adn Critical Parameters?

Hoping a reply with reference to any guideline.

Regards,

kvkiran
Validation analyst

2

[quote=kvkiran]Dear All,

1.Can anyone mention what are the critical parameters that are to be considered when performing the Retrospective Valdiation of Tablets, Liquids, Gels and Suspension? If so, can u please provide me the reference / guideline?

  1. What are Definitions of Critical Processes adn Critical Parameters?

Hoping a reply with reference to any guideline.

Regards,

kvkiran
Validation analyst[/quote]

Dear Kvkiran
Some of the essential elements for retrospective validation are:
• Batches manufactured for a defined period (minimum of last ten consecutive batches)
• Number of lots released per year.
• Batch size /strength /manufacturer /year /period.
• Master manufacturing/packaging documents.
• Current specification for active materials/finished products.
• List of process deviation, corrective actions and changes to manufacturing documents.
• Data for stability testing for several batches.
• Trend analysis including those for quality related complaints.

Crititcal Process Parameter (CPP) identified using a risk analysis investigated extensively using design of experiment (DOE).

Thanks and best regards,

3

Dear Mr.Shahnawaz,

Thank you for the information provided.

If iam not mistaken the above mentioned criteria are included in the feasibility study for performing a retrospective validation.

How are going to select among quality control parameters for tablets and Liquids (which includes Uni.Wt, Assay, Thickness, Hardness, pH, Viscosity, wt/ml and Assay) for analyzing and applying the statastics for capability study?

Plz do reply me.

Thanking you & Regards,

kvkiran
Validation analyst

4

[quote=kvkiran]Dear Mr.Shahnawaz,

Thank you for the information provided.

If iam not mistaken the above mentioned criteria are included in the feasibility study for performing a retrospective validation.

How are going to select among quality control parameters for tablets and Liquids (which includes Uni.Wt, Assay, Thickness, Hardness, pH, Viscosity, wt/ml and Assay) for analyzing and applying the statastics for capability study?

Plz do reply me.

Thanking you & Regards,

kvkiran
Validation analyst[/quote]

Dear Kvkiran,
Offcourse apply process capabilty test on varies QC test including chemical and physical as defined above and determine and validate the processes. and also it is better to perform annual product review. By applying six sigma appraoch evaluate the process limits.
thanks

5

[quote=kvkiran]Dear Mr.Shahnawaz,

Thank you for the information provided.

If iam not mistaken the above mentioned criteria are included in the feasibility study for performing a retrospective validation.

How are going to select among quality control parameters for tablets and Liquids (which includes Uni.Wt, Assay, Thickness, Hardness, pH, Viscosity, wt/ml and Assay) for analyzing and applying the statastics for capability study?

Plz do reply me.

Thanking you & Regards,

kvkiran
Validation analyst[/quote]

Dear Kvkiran,

you can ask freely If you have further querry,

Thanks and best regards