1648231_634945835378780000

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


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


SCHEDULE M

• PRODUCTION AREA:

• PRODUCTION AREA DESIGN SHOULD BE UNIFLOW

• AREA FOR DAYSTORE-AREA FOR WORK IN PROCESS

• ALL UTILITY LINES SHOULD BE DESIGNATED


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


SCHEDULE M

• QUALITY CONTROL AREA:

• LABORATORY AREA SHOULD BE SEPERATE

• SEPARATE SECTIONS FOR CHEMICAL. INSTRUMENTATION AND MICRO.

•


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


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.


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


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.


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 .


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.


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


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.


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..


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


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


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


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.


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.


SCHEDULE M

• MASTER FORMULA RECORDS:

• MF FOR EACH PRODCUT AND BATCH SIZE PREPARED AND SIGNED AUTHORISED BY COMPETENT PERSONNEL.


SCHEDULE M

• PACKING RECORDS:

• AUTHORISED PACKING RECORDS FOR EACH PRODCUT, PACK SIZE AND TYPE.


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.


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.


SCHEDULE M

• STANDARD OPERATING PROCEDURE (SOP) AND RECORDS:

• RECEIPT OF MATERIAL.

• SAMPLING.

• BATCH NUMBERING.

• TESTING.

• RECORDS OF ANALYSIS.


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.


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.


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.


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.


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.


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.


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.


SCHEDULE M

• SITE MASTER FILE:

• PRODUCTION.

• QUALITY CONTROL.

• LOAN LICENCE MANUFACTURE AND LINCENSEE.

• DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL.

• SELF INSPECTION.

• EXPORT OF DRUGS.


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.


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).


SCHEDULE M

• PART 1C: MFG OF ORAL LIQQUIDS(SYRUPS, ELIXERS, EMULSIONS & SUSPENSIONS)

• BUILDING AND EQUIPMENT.

• PURIFIED WATER.

• MANUFACTURING.

• FILLING

• PACKING.


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


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.


cGMP solutions…L RAMA RAO

986667926


1648231_634945835378780000

Documents

lrama rao cgmpsolutions

site master file

quality control system

batch packing records

reference samples

quality audit

authorised person

lock