Upload
raghuveer-bheemshetty
View
10
Download
2
Tags:
Embed Size (px)
DESCRIPTION
drugs and cosmetics act
Citation preview
SCHEDULE MINDIAN DRUGS & COSMETICS ACT
L RAMA RAO
cGMP solutions...
9866647926
08-04-23LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• GENERAL REQUIREMENTS:
• LOCATIONS AND SORROUNDINGS
• BUILDINGS AND PREMEISES
• WATER SYSTEM
• DISPOSAL OF WASTE
08-04-23 2LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• WARE HOUSING AREA:• RECEIVE AND DISPATCH BAYS SHALL PROTECT
PRODUCTS.
• SEPARATE AREA FOR QUARANTINE, SAMPLING
• REJECTED AREA SHOULD BE UNDER LOCK&KEY
• MATERIAL SHOULD BE PLACED ON PALETTES
• MATERIALS EARMARKED AS PER COMPATIBILITY
• PRINTED PAKAGING MATERIALS SHALL BE LOCK &KEY
08-04-23 3LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• WAREHOUSING AREA:
• RODENT AND INSECT CONTROLLING
• TEMPERATURE AND HUMIDITY RECORDS
• SEPARATE AREA FOR DISPENSING
• DOCUMENTATION IN-WARD AND OUT-WARD
• ADEQUATE LIGHTING TO BE PROVIDED
• APPROVED AREA FOR APPOVED MATERIALS
• STATUS LABLES TO BE AVAILABLE
08-04-23 4LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PRODUCTION AREA:
• PRODUCTION AREA DESIGN SHOULD BE UNIFLOW
• AREA FOR DAYSTORE-AREA FOR WORK IN PROCESS
• ALL UTILITY LINES SHOULD BE DESIGNATED
08-04-23 5LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• ANCILLARY AREAS:
• REST AND REFRESHMENT AREAS SEPERATED
• FACILITIES FOR CHANGE ROOM AND TOILETS SEPERATED FOR BOTH SEXES
• MAINTENANCE WORK SHOP SEPARATE
• ANIMALS FOR SEPARATE IF REQUIRED
08-04-23 6LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• QUALITY CONTROL AREA:
• LABORATORY AREA SHOULD BE SEPERATE
• SEPARATE SECTIONS FOR CHEMICAL. INSTRUMENTATION AND MICRO.
•
08-04-23 7LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PERSONNEL:
• UNDER SUPERVISION OF TECHNICAL STAFF
• HEAD OF QC AND QA SHOULD BE SEPARATE FROM PRODUCTION.
• WRITTEN DUTIES OF TECHNICAL AND QC STAFF
• ADEQUATE NUMBER OF PERSONS EMPLOYED
• TRAINING REQUIRED FOR BOTH QC&QA, PRODUCTION
08-04-23 8LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• HEALTH, CLOTHING AND SANITATION OF WORKERS:• ALL PERSONNEL SHOULD BE MEDICALLY TESTED• ALL PERSONNEL SHOULD BE TRAINED ON PERSONNEL
HYGIENE.• SICK PERSONNEL SHOULD NOT BE ALLOWED IN
PRODUCTION.• ALL PERSONNEL SHOULD WEAR APPROPREATE CLOTHING • CHEWING , SMOKING, EATING, PLACING PLA NTS NOT
PERMITTED.
08-04-23 9LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• MANUFACTURING OPERATIONS AND CONTROLS:
• ALL OPERATIONS ARE UNDER SUPERVISION OF TECHINICAL STAFF.
• EACH CRITICAL STEP, MEASURING AND ADDING TO PROCESS BY TRAINED PEOPLE.
• PRECAUTIONS AGAINST MIX-UPS AND CROSS CONTAMINATION.
• MATERIAL UNDER PROCESS SHOULD BE PROPERLY LABELED
08-04-23 10LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• SANITATION IN THE MANUFACTURING PREMISES:
• PREMISES SHALL BE CLEANED AND MAINTAINED ORDERLY MANNER.
• ROUTINE SANITATION PROGRAMME AND CLEANING AS PER SCHEDULE.
• PRODUCTION AREAS SHALL BE WELL LIT.
08-04-23 11LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• RAW MATERIALS:
• RAW MATERIALS INVENTORY RECORDS AS PER SCHEDULE U.
• INCOMMING MATERIAL SHALL BE ARRANGED ORDERLY MANNER IN QUARANTINE AREA.
• ALL INCOMMING MATERIALS ARE FROM APPROVED SOURCE PREFERABLY FROM MANUFACTURER.
• RAW MATERIALS SHALL BE LABELED APPROPREATELY.
• “UNDER TEST”, “APPROVED” AND “REJECTED” LABELS PASTED .
08-04-23 12LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• RAW MATERIALS:
• CONTROLLED TEMPERATURE SHALL BE MAINTAINED.
• SAMPLED CONTAINERS SHALL BE IDENTIFIED.
• ONLY APPROVED MATERIALS AND WITHIN SHELF LIFE PRODUCTS TO BE USED IN PRODUCTION.
• ALL MATERIALS SHOULD BE PLACED ABOVE THE GROUND LEVEL/RAISED PLATFORM.
08-04-23 13LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• EQUIPMENT:
• EQUIPMENT LOCATED, DESIGNED, CONSTRUCTED, ADAPTED TO SUIT TO PROCESS.
• EACH EQUIPMENT SHALL BE PROVIDED WITH LOGBOOK.
• EQUIPMENT PLACED FOR EASY CLEANING AND SUITABLE FOR MANUFACTURING AND MAINTENANCE.
• PARTS OF PRODUCTION EQUIPMENT LUBRICATED WITH EDIBLE OIL TO AVOID CONTAMINATION.
• DEFECTIVE EQUIPMENT SHALL BE REMOVED.08-04-23 14LRAMA RAO
cGMPsolutions...9866647926
SCHEDULE M
• DOCUMENTATION AND RECORDS:
• DOCUMENTATION IS ESSENTIAL PART OF QA.
• DOCUMENT DESIGNED, PREPARED, REVIEWED AND CONTROLLED WHERE EVER APPLICABLE.
• DOCUMENTS SHALL BE APPROVED, SIGNED AND DATED BY AUTHORISED PERSON .
• DOCUMENTS SHALL BE REGULARLY REVIEWED,
KEPT UPTO DATE.
• ALL DOCUMENTS SHALL BE RETAINED AS PER SOP.08-04-23 15LRAMA RAO
cGMPsolutions...9866647926
SCHEDULE M
• LABELS AND PRINTED MATERIALS:
• LABEL SHALL CARRY THE DETAILS OF THE PRODUCT.
• ALL CONTAINERS, EQUIPMENT SHALL BEAR LABELS.
• ALL PRINTED LABELS SHALL BE KEPT UNDER LOCK & KEY, LEAFLETS AND OTHER PRINTED MATERIAL KEPT SEPERATELY.
• DOCUMENTS SHALL BE REGULARLY REVIEWED, KEPT UPTO DATE.
• RECORDS OF RECEIPT OF LABELING AND PAKING MATERIALS SHALL BE KEPT UPTO DATE.
• UNUSED CODED LABELS & PACKING MATERIALS SHALL BE DESTROYED AND RECORDED.
08-04-23 16LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• QUALITY ASSURANCE:• QA IS WIDE RANGE OF CONCEPT CONCERNING TO
ALL INDIVIDUALLY OR COLLECTIVELY.
• ADEQUATE ARRANGEMENTS ARE MADE FOR MANUFACTURE, SUPPLY AND USE OF CORRECT MATERIALS
• ALL PRINTED LABELS SHALL BE KEPT UNDER LOCK & KEY, LEAFLETS AND OTHER PRINTED MATERIASL SHALL BE KEEPT SEPERATELY.
• DOCUMENTS SHALL BE REGULARLY REVIEWED, KEPT UPTO DATE.
• ALL MATERIALS ARE TESTED AND RLEASED BY AUTHORISED PERSONS..
08-04-23 17LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• SELF INSPECTION AND QUALITY AUDIT:• SELF INSPECTION SHALL BE FOLLOWED TO
EVALUATE FOR MFG COMPLIANCE WITH GMP.
• TEAM TO BE CONSTITUED FROM ALL DEPARTMENTS.
• TEAM MEMBERS ARE EXPERIENCED, UNBIASED, QUALIFIED.
• TEAM RECOMMENDATIONS FOR CORRECTIVE ACTIONS SHALL BE ADOPTED.
• SCHEDULE TO BE PREPARED AND ADOPTED.
• AREAS: PERSONNEL, • Premises including personnel facilities. • Maintenance of buildings and equipment
08-04-23 18LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• SELF INSPECTION AND QUALITY AUDIT:
• AREAS:
• Storage of starting materials and finished products
• Equipment• Production and in-process controls• Quality Control• Documentation• Sanitation and hygiene08-04-23 19LRAMA RAO
cGMPsolutions...9866647926
SCHEDULE M
• SELF INSPECTION AND QUALITY AUDIT:• AREAS:
• Validation and revalidation programmes• Calibration of instruments or measurement
systems.• Recall procedures• Complaints management• Labels control• Results of previous self-inspections and any
corrective steps taken08-04-23 20LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• QUALITY CONTROL SYSTEM:
• IT SHALL BE ENSURED THAT ALL QC ARRANGEMENTS ARE EFFECTIVELY CARRIED OUT
• MANUFACTURER SHOULD HAVE OWN QC DEPT.
• QC MAY BE DEVIDED INTO CHEMICAL, INSTRUMENTATION AND MICRO AS REQUIRED.
• QC SHALL EVALUATE, MAINTAIN AND STORE REFERENCE SAMPLES.
• SOP’S SHALL BE AVAILABLE FOR ALL OPERATIONS.• NO BATCH SHALL BE RELEASED WITHOUT TESTING
08-04-23 21LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• QUALITY CONTROL SYSTEM:• REFERENCE SAMPLES SHALL BE KEPT FOR 3MONTHS
AFTER EXPIRY OF THE PRODUCT.• QC SHALL HAVE ACCESS TO PRODUCTION AREA • QC SHALL TEST FOR STABILITY AND ASIGN SHELF LIFE
OF PRODUCT.• QC INCHARGE WILL ADDRESS ALL COMPLAINTS AND
MAINTAIN RECORDS.• ALL INSTRUMENTS SHALL BE CALIBRATED• SPECIFICATION OF RM.INTERMEDIATE, FP & PACKING
MATERIALS ARE MAINTAINED BY QC.
08-04-23 22LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• SPECIFICATION:
• FOR RAW MATERIALS AND PACKING MATERIALS.
• FOR PRODUCT CONTAINERS AND CLOSURES.
• FOR INPROCESS AND BULK PRODUCTS.
• FOR FINISHED PRODUCTS.
• FOR PREPARATION OF CONTAINERS AND CLOSURES.
08-04-23 23LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• MASTER FORMULA RECORDS:
• MF FOR EACH PRODCUT AND BATCH SIZE PREPARED AND SIGNED AUTHORISED BY COMPETENT PERSONNEL.
08-04-23 24LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PACKING RECORDS:
• AUTHORISED PACKING RECORDS FOR EACH PRODCUT, PACK SIZE AND TYPE.
08-04-23 25LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• BATCH PACKING RECORDS:
• BATCH PACKING RECORDS FOR EACH BATCH OR PART BATCH PROCESSED.
• CHECKS SHALL BE MADE BEFORE PACKING, REGARDING PREVIOUS MATERIAL, DOCUMENTS AND ANY ITEMS.
• CHECK FOR PACKING EQUIPMENT AND AREA IS CLEAN.
08-04-23 26LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• BATCH PROCESSING RECORDS:
• BATCH PROCESSING RECORD FOR EACH PRODUCT AND CURRENT STATUS.
• CHECK FOR QA SIGNED AND STAMPED.
• BEFORE STARTING OPERATION, OLD RECORDS AND LEFTOVER MATERIAL REMOVED AND CLEANED.
• RECORD WRITING SHALL BE IMMEDIATE AFTER ACTIVITY.
08-04-23 27LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• STANDARD OPERATING PROCEDURE (SOP) AND RECORDS:
• RECEIPT OF MATERIAL.
• SAMPLING.
• BATCH NUMBERING.
• TESTING.
• RECORDS OF ANALYSIS.
08-04-23 28LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• REFERENCE SAMPLES:
• EACH LOT OF API SHALL BE RETAINED FOR 3MONTHS OF EXPIRY OF PRODUCT.
• QUANTITY SHOULD BE FOR TESTING ALL TESTS.
• FINISHED PRODUCT SAMPLES SHALL BE KEPT IN SIMULATED TO PACKING MATERIAL.
• RECORDS TO BE MAINTAINED.
08-04-23 29LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• REPROCESSING AND RECOVERIES:
• WRITTEN PROCEDURE APPROVEDBY QA SHALL SPECIFY CONDITIONS AND LIMITATIONS.
• PROCEDURE SHALL BE VALIDATED. • AN INVESTIGATION SHALL BE CARRIED OUT FOR
REASONS WHICH NECITITATED AND CORRECTIVE ACTION BY AUTHORISED PERSON.
• SHALL BE SUBJECTED TO STABILITY TESTING.• RECOVERY OF PRODUCT RESIDUE MAY CARRIED OUT
IF PROCEDURE PERMITS.
08-04-23 30LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• DISTRIBUTION RECORDS:
• PRIOR TO DESPATCH ENSURE BATCH HAS BEEN TESTED AND APPROVED.
• PRE DESPATCH CHECKS CAN BE DONE ON RANDOM BASIS.
• PERIODIC OF AUDITS AT WAREHOUSE DISTRIBUTION OUTLETS FOR GMP PRACTICES.
• SOP SHALL BE AVAILABLE FOR OPERATIONS.• RECORDS TO BE MAINTAINED FOR TRACEABILITY.
08-04-23 31LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• VALIDATION AND PROCESS VALIDATION:
• IT IS ESSENTIAL AS PER GMP DONE AT PRE-DEFINED PROTOCOLS.
• A WRITTEN RECORDED RESULTS AND CONCLUSIONS SHALL BE DOCUMENTED.
• ESTABLISHED PROCESSES AND PROCEDURES SHALL UNDER GO REVALIDATION FOR SURITY.
• CRITICAL PROCESSES SHALL VALIDATED PERIODICALLY.• SIGNIFICANT CHANGES TO PROCESS SHALL BE
VALIDATED.
08-04-23 32LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PRODUCT RECALLS:
• A PROMPT AND EFFECTIVE SYSTEM SHALL BE DEVISED.
• A WRITTEN PROCEDURE (SOP) FOR RECALL.
• DISTRIBUTION OF RECORDS TO BE MAINTAINED.
• RECONCILATION REQQYUIRED FOR QUANTITIES.
• RECALLED PRODUCTS SHALL BE KEPT AT DESIGNATED PLACES UNDER CONTROL.
08-04-23 33LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• COMPLAINTS AND ADVERSE REACTIONS:
• A LL COMPLAINTS SHALL CAREFULLY REVIEWED AND RECORDED.
• EACH COMPLAINT SHALL BE INVESTIGATED BY DESIGNATED PERSON.
• RECORDS OF INVESTIGATION AND REMIDIAL ACTION TO BE MAINTAINED.
• REPORTS OF SERIOUS ADVERSE REACTIONS SHALL BE INFORMED TO LICENSING AUTHORITY.
• AN SOP SHALL BE AVAILABLE FOR COMPLAINTS.
08-04-23 34LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• SITE MASTER FILE:
• A SPECIFIC AND FACTUAL INFORMATION OF GMP AT PRODUCTION AND CONTROL AT MFG UNIT.
• GENERAL INFORMATION. • PERSONNEL.• PREMISES.• EQUIPMENT.• SANITATION.• DOCUMENTATION.
08-04-23 35LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• SITE MASTER FILE:
• PRODUCTION.
• QUALITY CONTROL.
• LOAN LICENCE MANUFACTURE AND LINCENSEE.
• DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL.
• SELF INSPECTION.
• EXPORT OF DRUGS.
08-04-23 36LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PART 1A: MFG OF STERILE PRODUCTS LVP, SVP AND OPTHALMIC PREPARATIONS
• GENERAL.• BUILDING AND CIVIL WORKS. • AHU ( AIR HANDLING UNITS).• ENVIRONSMENAL MONITORING.• GARMENTS.• SANITATION.• EQUIPMENTS ETC.
08-04-23 37LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PART 1B: MFG OF ORAL SOLID DOSAGE(TABLETS, CAPSULES)
• GENERAL.• SHITING, MIXING AND GRANULATION. • COMPRESSIONS.• COATING(TABLETS).• FILLING (HARD GELATIN CAPSULE).• PACKING (STRIP & BLISTER).
08-04-23 38LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PART 1C: MFG OF ORAL LIQQUIDS(SYRUPS, ELIXERS, EMULSIONS & SUSPENSIONS)
• BUILDING AND EQUIPMENT.
• PURIFIED WATER.
• MANUFACTURING.
• FILLING
• PACKING.
08-04-23 39LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PART 1D: MFG OF TROPICAL PRODUCTS(CREAMS, OINTMENTS, LOTIONS)
• PAT1E: MFG OF METER DOSAGE INHALERS.
• GENERAL.• ENVIRONMENTAL CONDITIONS. • GARMENTS.• SANITATION• EQUIPMENT & MANUFACTURE.• DOCUMENTTION
08-04-23 40LRAMA RAO cGMPsolutions...9866647926
SCHEDULE M
• PART1F: MFG OF ACTIVE PHARMACEUTICAL INGREDIENTS (BULK DRUGS)
• BUILDING AND CIVIL WORKS.
• UTILITIES/SERVICES.
• EQUIPMENT DESIGN, AND SITE LOCATION.
• IN-PROCESS CONTROLS.
• PRODUCT CONTAINERS AND CLOSURES.
08-04-23 41LRAMA RAO cGMPsolutions...9866647926
cGMP solutions…L RAMA RAO
986667926
08-04-23 42LRAMA RAO cGMPsolutions...9866647926