Sop for Quality control procedures

This Document describes (Standard Operating procedure) Sop for Quality control procedures.

Sop for Quality control procedures.

I. PURPOSE AND SCOPE:

• The Purpose of this SOP is to lay down the procedure to lay down working instructions for Quality control procedures
• This procedure is applicable for working instructions for Quality control procedures

II. RESPONSIBILITIES :

• All  Quality Control personnel’s shall be responsible to follow and implement this SOP.

III : INTRODUCTION AND PROCEDURAL PART :

1) INSTRUCTIONS:

• Maintain cleanliness of laboratory and equipment. Handle it carefully.
• During analysis, use appropriate safety appliances such as hand gloves, nose masks etc.
• Handle the hazardous chemicals as per SOP for Handling of hazardous chemicals.

2) TESTING AND RELEASE OF MATERIALS / PRODUCT:

• QC Manager or designee shall allocate the work to individual analyst of analysis or documentation in work output report as per Annexure I on daily basis.
• All analyst shall fill their individual work output report at the end of day and handover to QC head or designee for review.
• Raw materials/Packaging Materials/Intermediate Products/finished Products analysis shall carry out as per respective Specification. In case of Raw materials and packaging materials, verify label details against Raw/ Packing Material Inspection report and in case of finished products cross check and verify the overprinting details on each sample pack.
• Send the material to external testing laboratory for which in-house facility is not equipped; Release these materials after receipt of report from the respective laboratory.
• Keep the working table neat and clean.
• Store chemicals, reagents and volumetric solution in properly closed conditions and at the designated places. Do not use the solutions beyond validity date as per quality control procedures.
• Do not use broken glassware. If found then discard these glassware and new glassware shall be issued for analysis.
• Use rubber bulb for pipetting the solution. Do not suck the solution by mouth.
• Ensure the calibration status of instruments before use.
• Make necessary entries in respective register but not limited to in Instruments usage log book and Media Consumption record as a part of quality control procedures.
• Reference/Working standards consumption record.
• Volumetric Solution Record.
• Record all observations in test data sheet of respective material or common test data sheets during analysis. Avoid overwriting, in case of overwriting strike out the wrong figure in such a way that it should be clear and legible and enter corrected figure and sign. Do not use unauthorized notebooks or pads.
• After completion of analysis, prepare final report in standard format. Make necessary entries in required documents and send the Final report along with GRN to Quality Control Manger for authorization.
• After receipt of report and GRN from Quality Control Manager, submit the complete report to QA Department.
• Finished product report, process validation sample analysis report ,inprocess sample analysis report to QA Department for further Process as a part of quality control procedures.
• Discard the balanced sample quantity as per SOP for destruction of Samples after analysis.
• File the analytical reports in the respective file along with the necessary documents.

3) STABILITY SAMPLE TESTING:

• The stability studies are to understand any chemical, physical, microbiological changes, to which drug product may expose during life cycle, to confirm drug products for efficacy and safety and for the regulatory requirements.
• Stability studies for all the finished products shall be conducted as per SOP for stability studies.
• Selection of batches, sampling and stability test conditions shall be as per SOP for stability studies.
• Stability test Parameters shall be as per stability protocol of respective product.
• Carry out the analysis of stability samples as per respective specification and the method used for analysis shall be stability indicating.
• Maintain the stability data as per the protocol.
• Maintain temperature and humidity record of all Stability chambers as a part of quality control procedures.

4) WORKING STANDARDS AND REFERENCE STANDARDS:

• Working standards shall have high purity, critical characteristics and suitability for intended purpose.
• Working standard vials shall be prepared as per requirements as per SOP for preparation of Working standards.
• Unless otherwise specified, the validity of working standard is one year. from the Date of preparation.
• One vial of working standard shall be used for three months. After three months discard the initial vial and another vial shall be opened for use after making necessary entries in working standard register as per quality control procedures.
• Reference standards shall be procured only from the authorized sources.
• Reference standards shall be stored and used as per SOP and instructions given on reference standards vial or certificate of analysis.

5) VOLUMETRIC SOLUTIONS:

• Volumetric solutions shall be prepared as per SOP for preparation and standardization of volumetric solutions
• The actual strength of volumetric solutions should be within + 10% of prescribed strength and determine with a precision of not more than + 2%.
• Volumetric solutions shall be labelled as per format and used as per the validity date mentioned on label.
• Do not use solutions, which becomes hazy, show precipitation or colour change.

6) HANDLING OF GLASS WARE:

• All the glassware shall be procured from reputed manufacturer/supplier.
• Make a record for receipt of glassware.
• Cleaning of glassware shall be done as per SOP as a part of quality control procedures.
• Do not use broken glassware.
• While keeping any glassware on gas burner for heating, use tripod stand and wire gauze for uniform heating and put some glass beads in the solution to avoid bumping while boiling.

7) RETESTING OF RAW MATERIALS :

• It is necessary to retest and reconfirm the properties and potency of all released material in stock as per predetermined standards after certain period.
• At the interval of two month stores officer shall send the list of raw material due for retesting to QC Departments.
• QC person shall intimate to IPQA person to perform sampling of these material as per SOP for Sampling of Raw and  Packing Material   and shall provide to QC department  for testing of these material so that the material shall be released on or before due date.
• Follow the procedure as per SOP for Retesting of Raw materials

8) VALIDATION:

• All analytical methods used for analysis of various dosage forms shall be validated.
• Carry out Analytical method validation as per the analytical method validation protocol and prepare the Analytical Validation Report as a part of quality control procedures.
• All the equipment used for manufacturing shall be validated for cleaning procedure
• Carry out cleaning validation as per the respective Cleaning validation protocol.
• All the manufacturing process shall be validated.
• Carry out process validation as per the process validation protocol.
• Analyst Certification shall be conducted for all personnel working in Quality Control Department as a part of quality control procedures.

9) CALIBRATION:

• Perform the calibration of instruments as per calibration calendar.
• Ensure the calibration status of instrument before use.
• Instruments which are under maintenance shall be labeled as “Instrument under maintenance “.

10) FREQUENCY:

• As and when required.

11) ANNEXURE:

Annexure I: WORK OUTPUT RECORD

ANNEXURE I

WORK OUTPUT RECORD

Name of Analyst:_______________________________              Date: _____________

Status: Write “C” for Completed, “NC” for Not Completed and “P” for pending and “AN” for Analysis or Activity is going on.

Allocated By:_________________            Analyst :___________ Reviewed By:__________

Sign/date:                                                    Sign/date:                       Sign/date: