sop for cleaning validation in pharma
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for cleaning validation.
2.0 SCOPE
2.1 This SOP is applicable for cleaning validation
3.0 RESPONSIBILITY
3.1 Executive –Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager –Quality Assurance -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance Department / Chief Executive Officer
5.0 PROCEDURE
5.1 This cleaning procedure for cleaning of used equipment(s) and facility after the manufacturing processes shall be validated. Validated of all such cleaning procedures used in between product change over shall be validated prior to routine implementation. Following procedure shall be adopted to conduct cleaning validation.
5.1.1 In case of solid dosage forms, an individual drug based solubility matrix shall be prepared upon which the cleaning validation shall be executed for worst case determination of target product for cleaning validation. following procedure shall be adopted to conduct cleaning validation.
5.1.2 A cleaning procedure for equipment, floor etc. shall be developed and standard operating procedure shall be prepared. during development of cleaning procedure areas, which are difficult to clean and hard to reach shall be considered.
5.1.2.1 The cleaning procedure shall be based on the scientific rational solubility, toxicity and therapeutic category and dosage of material to be cleaned.
5.1.2.2 Analytical testing procedure for cleaning sample shall be developed validated with the involvement of PTD/analytical service department at QA of tie up company.
5.1.2.3 In case it not provided by tie up company then it is the responsibility of QA department to develop and validate the procedure.
5.1.2.4 The analytical method of cleaning samples shall be validated for Precision, linearity, accuracy, specificity, LOD (limit of detection) and LOQ (limit of quantization).
5.1.2.5 The QA head shall authorize cleaning validation protocol, clearly indicating objective, scope, and the acceptance limits/criteria, sampling plan and procedures and revalidation criteria (refer to cleaning validation master plan). Following shall be considered and included in the cleaning validation protocol:
5.1.2.6 Sampling plan of cleaning samples.
5.1.2.6.1 Acceptance criteria for cleaning validation: acceptance criteria shall be based on the either one or more of the visually clean, 10 PPM, 0.001 of dose criteria and scientific rational of maximum allowable carry over (MAC) base formula of previous product contamination in to next product. for product change over cleaning the most stringent acceptance limits shall be taken as the acceptance criteria. whereas for batch-to¬-batch cleaning of same product only “visually clean” criteria shall be accepted.
5.1.2.6.2 Three consecutive batches shall be taken for cleaning validation studies. after manufacture of each batch, all equipment and accessories shall be cleaned thoroughly, as per the standard operating procedure for cleaning.
5.1.2.6.3 Rinse sample shall be collected to evaluate the cleaning procedure. Swab samples shall be collected from critical areas of the equipment, which are difficult to clean.
5.1.2.6.4 Samples shall be collected by swabbing, the known equipments are with swabs (membrane filter) moistened with a suitable solvent rubbing the known area horizontally, and vertically. The number of strokes shall be decided on the basis of recovery study.
5.1.2.6.5 To evaluate the effectiveness of swab sampling, a known amount of sample shall be spiked in the known area of same material of construction as equipment. The spiked materiel shall be allowed to dry, and than sampled by Swabbing. Swabbed material shall quantify and the amount recovered (recovery study) shall be into account.
5.1.2.6.6 The cleaning rinse samples shall be analyzed by using the validated analytical method.
5.1.2.6.7 Swab samples shall be extracted in a suitable solvent and then analysed as per the validated method and the left over residue after cleaning shall be quantified. The results of analysis of swab samples shall be corrected by the percentage of recovery study.
5.1.2.6.8 The results of analysis of cleaning shall meet the acceptance criteria.
5.1.2.6.9 At the time of validation activity of cleaning method validation, residue verification of active analyte, will be done by using equipment like HPLC (preferred), UV, autotitrator, etc. and parallel study will be done on TOC (Total Organic Carbon) Analyser to verify the cleaning method.
5.1.2.6.10 To the routine evaluation cleaning procedure of equipment TOC analyser will be used.
5.1.2.6.11 Cleaning of plant will be done by following the for Cleaning policy of the
6.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
HPLC : High Performance Liquid Chromatography
TOC : Total Organic Carbon
UV : Ultra Violet