Selection of worst case product & product matrix

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear all,

please clarify to me

for the selection of Worst Case products and preparation of product matrix (Which parameters we have to select?).

2

Dear vamsemicro

Following citeria are to be selected for selection of Worst case

1.Therapeutic class
Therapeutic class shall be considered for the selection of molecules.

2.Drug potency
The Drug having highest potency shall be considered for the selection. Within the selected molecule of having various strength the drug with highest strength shall be considered.

3.Solubility
The drug with least solubility in water shall be considered for the selection .

4.Specific method of cleaning
Product involving use of specific cleaning method or use of cleaning agent cleaning agent shall be considered.

If you have any query you can contact at francisf@glenmarkpharma.com

3

Dear francis, if i am not wrong, am i talking to francis fernandes? i came to know about you from Anthony Thomas.

i have a question regarding selecting highest potency from a group of products.

If we have following active ingredients running on a common equipment train, then based on highest potency, which one is the worst case:

Enalapril maleate, strength 2.5 mg, 5 mg and 10 mg
Clonazepam, strength 0.5 mg and 2 mg
Paracetamol, strength 500 mg
Clordiazepoxide, strength 10 mg and 25 mg

Regards,
Sanjeev Setia
ssetia@nicholaspiramal.co.in

4

Dear Sanjeev

Name of Molecule Category Solubility Potency Lowest Dose Highest Dose
Enalapril maleate
CARDIAC DRUGS
Slightly soluble in water 2.5mg 2.5mg 20 mg
Clonazepam
BENZODIAZEPINES Insoluble 0.125mg 0.125mg 2mg
Clordiazepoxide
BENZODIAZEPINES Soluble in water 5mg 5mg 25mg

With this Matrix we have three products

In case of solubility and potency we will consider Clonazepam and to carry out actual validation for strength in this product then we will select Higher strength which is mfg on this line ( Reason for selection of higher strength is if you can clean higher strength then low strength can be clean easily)

Regards

Francis Fernandes
francisf@glenmarkpharma.com

5

can used train of equipment used for worst case.
pls specify.

prasad

[quote=fransha]Dear vamsemicro

Following citeria are to be selected for selection of Worst case

1.Therapeutic class
Therapeutic class shall be considered for the selection of molecules.

2.Drug potency
The Drug having highest potency shall be considered for the selection. Within the selected molecule of having various strength the drug with highest strength shall be considered.

3.Solubility
The drug with least solubility in water shall be considered for the selection .

4.Specific method of cleaning
Product involving use of specific cleaning method or use of cleaning agent cleaning agent shall be considered.

If you have any query you can contact at francisf@glenmarkpharma.com[/quote]

6

[quote=pvalidation]can used train of equipment used for worst case.
pls specify.

prasad[/quote]

Well Parasad, Equipment Train represents One Manufacturing line fascility. Like in solid dosage form manufacturing area all equipments may be used in multi-product manufacture or dedicated to individual products, are to be taken in account, yes it is more important to evaluate equipment surfaces and determine Worst case locations (Hard to clean areas) to sample (swab sampling), Volume and type of rinse solvent to be employed (rinse sampling) and Equipment surface area (necessary to calculate carryover into subsequent batches)

7

Dear All,
Worst Case product can be selected as per the info given by Mr.Francis.

For preparation of Product Matrix…below instructions can be followed.

a) In case of Multi Product Facility:

Matrix shall be prepared w.r.t Equipment capacity (or)
Matrix shall be prepared w.r.t Cleaning Procedure (or)
Matrix shall be prepared w.r.t Category of Products (or)
Matrix shall be prepared for Product Vs Product (for MACO)

b) In case of Dedicated Product Facility:

Matrix shall be prepared w.r.t Equipment Capacity

We can apply this concept for Parenterals / Oral Dosage forms / APIs.

Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

8

Mr.Prasad,

If we consider “Train of Equipments” for Worst Case, then we need to consider the Highest Surface Area of Equipment Train, as it becomes the worst case for setting the limits for Swab / Rinse.

So, for multi-product facility, Highest Surface Area of Equipment Train can be followed in setting the Worst Case Limits.

Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com