Cleaning Validation

Views:
 
     
 

Presentation Description

No description available.

Comments

Presentation Transcript

CLEANING VALIDATION : 

CLEANING VALIDATION BY BALWANT JADHAV

WHAT IS VALIDATION ? : 

WHAT IS VALIDATION ? The process of providing documented evidences, that provides a high degree of assurance that specific process, method, will consistently produce a result with pre – determine acceptance criteria.

WHY VALIDATION IS NEEDED? : 

WHY VALIDATION IS NEEDED? To makes working easier and safer. To Sets the recognized level of Quality. To facilities integrability. To enhances efficiency. Validation Streamlines production, increases productivity. Before using in routine work like analysis or production.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION Analytical Method Validation Process Validation Software Validation Cleaning validation

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION Analytical Method Validation Validation:- Confirmation by examination and provision of object evidence that the particular requirements for a specific intended use can be consistently fulfilled.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION Verification:- Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION Process Validation:- Establishing documented evidence which Provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION Prospective validation :- Prospective validation is the most common level of validation, conducted prior to the commercial release of a product. Usually applied to the new facilities.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION CONCURRENT VALIDATION:- To demonstrate the validated state concurrent validation has to be conducted. There may be instances when it is appropriate to validate a process during routine production to ensure that the status is maintaining its validated status.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION RETROSPECTIVE VALIDATION :- Validation of the process using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do. Source data includes batch documents, process control charts, maintenance log books, finished product data and storage stability results.

VARIOUS TYPE OF VALIDATION : 

VARIOUS TYPE OF VALIDATION SOFTWARE VALIDATION:- When software or automated data processing systems are used as a part of the production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance.

CLEANING VALIDATION : 

Cleaning validation is the process of assuring that cleaning procedures effectively remove the residue from Manufacturing equipment / facilities below a predetermined level. CLEANING VALIDATION

Why cleaning procedures is necessary? : 

Why cleaning procedures is necessary? Pharmaceutical products and API can be contaminated by other pharmaceutical products, cleaning agent & microbiological contamination. It is regulatory requirement in pharmaceutical product manufacture the concern is the same-assurance that equipment is clean and that product quality and safety are maintained. It is also assure from an internal control and compliance point of view the quality of manufacture.

LEVELS OF CLEANING : 

LEVELS OF CLEANING Levels of cleaning depends on The equipment usage The stage of manufacture The nature of the potential contamination

CLEANING VALIDATION PROCESS : 

CLEANING VALIDATION PROCESS Establishment of acceptance criteria Cleaning procedure Sampling procedure Analytical method and its validation Validation protocol

ESTABLISHMENT OF ACCEPTANCE CRITERIA : 

ESTABLISHMENT OF ACCEPTANCE CRITERIA Visual criteria 10ppm criteria Dose criteria Basis of calculation of acceptance criteria. it is based on potency, batch size and max dosing i.e. maximum allowable carry over (MACO).

MAXIMUM ALLOWABLE CARRY OVER (MACO) : 

MAXIMUM ALLOWABLE CARRY OVER (MACO) Formula MAC = I/J x K/L x M where I = smallest strength of product ‘A' (previous product) manufactured (safety factor 1000). J= maxim number of dose units of product ‘B’ (next product) administrated / day.

K= number of dose units per batch of product ‘B’. L= equipment surface area in common between products ‘A’ and ‘B’ expressed as square centimeters. M= sampling surface area ( product ‘A’ is previous product &product ‘B’is next product).

SAFETY FACTOR : 

SAFETY FACTOR 1/10th to1/100th of a Normal Daily Dose- Topical Products 1/100th to 1/1000th of a Normal Daily Dose- Oral Products 1/1000th to 1/10,000th of a Normal Daily Dose- Injections, Ophthalmic Products

MATRIX : 

MATRIX A matrix of the products shall be maintained, which shall state the cleanliness level achieved by the cleaning procedure . The matrix shall be updated upon introduction of any new product or batch size.

CLEANING PROCEDURE : 

CLEANING PROCEDURE Cleaning processes:- The equipment cleaning procedures involves any one of the following types of cleaning Process based on the manufacturing situation. Batch to Batch cleaning: clean with dry duster & Vaccum. Product to Product cleaning: cleaning by using soap solution followed by treated water, finally rinsing with purified water & mopping with Isopropyl alcohol.

SAMPLING PROCEDURE : 

SAMPLING PROCEDURE Direct surface sampling (swab method) -Possible to recover dried residues Indirect sampling (rinse method ) -Sampling from wide area is possible -Sampling is possible from a position not accessible by hand. sample shall be taken after the final cleaning of equipment.

ANALYTICAL METHOD AND ITS VALIDATION : 

ANALYTICAL METHOD AND ITS VALIDATION Analytical methods used to detect residuals or contaminants should be specific, sensitivity It should be validated before the cleaning validation study is carried out Only worst cases analytical method validation perform

INVESTIGATION OF WORST CASE : 

INVESTIGATION OF WORST CASE Hardest to clean :Experience from production Solubility in used solvent Highest toxicity Lowest Therapeutic dose Other scientific rationales The smallest strength &the most insoluble drug product dose shall be selected as worst case Worst case study is taken as standard

ANALYTICAL METHOD VALIDATION : 

ANALYTICAL METHOD VALIDATION PARAMETERS System suitability specificity Limit of detection and Limit of Quantitation Linearity and Limit of Quantitation Recovery Precision Ruggedness Stability of sample solution

VALIDATION PROTOCOL : 

VALIDATION PROTOCOL Objective Scope Equipment Assembly and cleaning procedure Cleaning records of the Equipments Sampling plan Method of Analysis Analytical Method Validation Validation summary

Slide 29: 

Documents Attached Any changes made against the formally agreed parameters Recomendations Review Post Approval Determination of worst case product Analytical raw data Microbiological Data Solubility Daily dose reference

Slide 30: 

ANY QUESTIONS ?

Slide 31: 

THANK YOU

authorStream Live Help