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Cleaning Validation

Cleaning Validation

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Published by Sophia

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Published by: Sophia on Dec 06, 2012
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09/19/2013

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Cleaning Validation
OBJECTIVE:
To describe the procedure for Cleaning Validation.
 
SCOPE:
Demonstrate and validate that current standard operating procedure for Cleaning can consistentlyclean the equipment to a pre-determined level of cleanliness.
 
Demonstrate that no cross contamination will be observed on shared equipment between drug productto be cleaned and next drug product to be manufactured.
 
RESPONSIBILITY:
Pharmacist, Executive- QA, Executive- QC, Head – Production, Head – QA & QC.
 
PROCEDURE:
The Cleaning validation is performed to demonstrate the effectiveness of procedures for Cleaning toremove residue of previous product.
 
After the process, equipments used for manufacturing of the product, shall be cleaned as mentioned inrespective SOPs for cleaning.
 
All procedures of cleaning of process equipments used to manufacture more than one product shall bevalidated.
 
If the product contains more than one active substance, the active substance least soluble in waterand/or highly potent is tested, unless otherwise specified in the individual specification.
 
Before initiating any cleaning validation, a product specific specification shall be prepared. Thespecification shall mention the acceptance criteria for the existing products, however if acceptancecriteria becomes stringent or maximum rinse volume is changed after addition of new products, theacceptance criteria and maximum rinse volume is communicated to concerned department. Thestringent acceptance criteria is added in the specifications during the scheduled periodic review of thespecifications.A specification shall minimally contain the following
 
Sampling quantity
 
Shall provide sampling quantity for chemical and microbiological testing or as applicable.
 
Sampling procedure
 
Shall explain briefly the procedure for sample collection.
 
Analytical specification
 
Shall provide specifications of the applicable tests.
 
Method of analysis
 
Shall provide analytical method for the applicable tests
 
 
All the applicable tests shall be incorporated in the specification itself.
 
Minimally three cleaning cycles shall be monitored and validated to establish the effectiveness of cleaning procedure.
Cleaning verification
 
Study of monitoring the cleaning activity before completion of the three cleaning cycles oncommercial batches of the product shall be considered as cleaning verification.
 
Cleaning verification / validation Acceptance Criteria:
 
Calculation of the maximum Allowable carryover ( MACO)For the calculation by considering 0.1 % Safety factor
Daily therapeutic dose Min. Batch Size of Product B
 
of product A in mg (in mg)Limit (mg) = ----------------------------------- x ------------------------------------------------1000 Max. daily therapeutic dose of product B in (mg)Where,
 
Product A – Product manufactured before cleaning
 
Product B – Next Product after cleaning
 
For Considering 10 ppm as acceptance criteria.
 
The quantity equivalent to 10 mg/L of the batch size is considered as the acceptance criteriafor the acceptance criteria as 10 ppm.
 
Calculation of acceptance criteriaCalculation of acceptance criteria for swab samples
 
Active Ingredient Residue (For Non-dedicated equipments): Acceptance criteria based on thefollowing rationale for swab samples :
 
Calculation [Applicable to all items of common equipment in product train].
 
1000
 
D
 
Limit (PPM) = MACO x ---------- x -----------
 
C VWhere,
 
C – Cumulative surface area of the equipments used (in cm
2
).
 
V – Volume of solvent used to dispense swab.
 
1000 – Multiplication factor to convert value in mcg from mg.
 
 
D – Swabbed Surface Area in cm
2
.
 
Calculation of acceptance criteria for Rinse samples
 
Active Ingredient Residue (For Non-dedicated equipments): Acceptance criteria based on thefollowing rationale for rinse samples:
 
Calculation [Applicable to all items of common equipment in product train].
 
1000
 
1
 
Limit (PPM) = MACO X -------------- x ------
 
C VWhere,
 
C – Cumulative surface area of the equipments used (in cm
2
).
 
V – Volume of solvent used for rinse of the same in mL per cm
2
of Equipment.
 
1000 – Multiplication factor to convert value in mcg from mg.
 
Calculation of recovery factor :
 
% Recovery shall be not less than 75% unless otherwise specified and justified in individualprotocol of analytical method validation. Recovery factor shall be calculated as follows:
 
Recovery factor shall be calculated as follows:
 
% Recovery
 
Recovery factor = --------------------
 
100
 
Microbiological Quality:a) A Total count limit, is Not more than 10 cfu/100 ml
 
by rinse method.
 
b) Not more than 5 cfu / 25 cm
2
 Cleaning validation shall be performed on all the products. The matrix for acceptance criteriashall be prepared when the same set of equipment is used for different products.
 
After addition of new product the acceptance criteria and maximum rinse volume shall berecalculated in matrix. If the acceptance criteria is stringent than as specified in theRevalidation of cleaning procedure:
 
Revalidation of cleaning procedure is required if any of the following occur and revalidationof cleaning procedure shall be performed on a minimum of three cleaning cycles.
 
Modification of cleaning procedure / Surface area of product contact parts of the equipmentor any modification to the equipment which has got direct bearing on product contact parts.
 
Change in cleaning procedure.

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