SCHEDULE M INDIAN DRUGS & COSMETICS ACT

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GENERAL REQUIREMENTS:
LOCATIONS AND SORROUNDINGS BUILDINGS AND PREMEISES WATER SYSTEM DISPOSAL OF WASTE

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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
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WAREHOUSING AREA:

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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
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PRODUCTION AREA:
PRODUCTION AREA DESIGN SHOULD BE UNIFLOW AREA FOR DAYSTORE-AREA FOR WORK IN PROCESS ALL UTILITY LINES SHOULD BE DESIGNATED

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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

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QUALITY CONTROL AREA:

LABORATORY AREA SHOULD BE SEPERATE SEPARATE SECTIONS FOR CHEMICAL. INSTRUMENTATION AND MICRO.

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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
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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. 07-0513 LRAMA RAO 9
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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 07-0513 LRAMA RAO 10 LABELED
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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.

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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 07 -0513 LRAMA RAO 12 PASTED . cGMPsolutions...9866647926

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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.

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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. 07 -0513 LRAMA RAO 14
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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.
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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. 07-05-13 LRAMA RAO 16 UNUSED CODED LABELS & PACKING MATERIALS cGMPsolutions...9866647926 SHALL BE DESTROYED AND RECORDED.

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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 17 07 -0513 LRAMA RAO cGMPsolutions...9866647926 AUTHORISED PERSONS..

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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,

07 Premises including personnel facilities. -05-13 LRAMA RAO cGMPsolutions...9866647926 Maintenance of buildings and equipment

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SELF INSPECTION AND QUALITY AUDIT:
AREAS:

Storage of starting materials and finished products Equipment Production and in-process controls Quality Control Documentation -05-13 LRAMA RAO 07Sanitation and hygiene cGMPsolutions...9866647926

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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 07-05-13 LRAMA RAO corrective steps cGMPsolutions...9866647926 taken

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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. SOPS SHALL BE AVAILABLE FOR ALL OPERATIONS. 07-05-13 LRAMA RAO 21 cGMPsolutions...9866647926 NO BATCH SHALL BE RELEASED WITHOUT TESTING

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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 & ARE MAINTAINED BY QC. 22 07-05-13PACKING MATERIALS LRAMA RAO
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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.

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MASTER FORMULA RECORDS:

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

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

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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.
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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.
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STANDARD OPERATING PROCEDURE (SOP) AND RECORDS:

RECEIPT OF MATERIAL. SAMPLING. BATCH NUMBERING. TESTING. RECORDS OF ANALYSIS.

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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.

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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. 07-05-13 LRAMA RAO 30
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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 07-05-13TRACEABILITY. LRAMA RAO 31
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VALIDATION AND PROCESS VALIDATION:

IT IS ESSENTIAL AS PER GMP DONE AT PREDEFINED 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 07-05-13 LRAMA RAO VALIDATED. cGMPsolutions...9866647926

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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.
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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.
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SITE MASTER FILE:

A SPECIFIC AND FACTUAL INFORMATION OF GMP AT PRODUCTION AND CONTROL AT MFG UNIT. GENERAL INFORMATION. PERSONNEL. PREMISES. EQUIPMENT. SANITATION. DOCUMENTATION.
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SITE MASTER FILE:

PRODUCTION. QUALITY CONTROL. LOAN LICENCE MANUFACTURE AND LINCENSEE. DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL. SELF INSPECTION. EXPORT OF DRUGS.
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PART 1A: MFG OF STERILE PRODUCTS LVP, SVP AND OPTHALMIC PREPARATIONS

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GENERAL. BUILDING AND CIVIL WORKS. AHU ( AIR HANDLING UNITS). ENVIRONSMENAL MONITORING. GARMENTS. SANITATION. EQUIPMENTS ETC.
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PART 1B: MFG OF ORAL SOLID DOSAGE(TABLETS, CAPSULES)

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GENERAL. SHITING, MIXING AND GRANULATION. COMPRESSIONS. COATING(TABLETS). FILLING (HARD GELATIN CAPSULE). PACKING (STRIP & BLISTER).
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PART 1C: MFG OF ORAL LIQQUIDS(SYRUPS, ELIXERS, EMULSIONS & SUSPENSIONS)
BUILDING AND EQUIPMENT. PURIFIED WATER. MANUFACTURING. FILLING PACKING.

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PART 1D: MFG OF TROPICAL PRODUCTS(CREAMS, OINTMENTS, LOTIONS) PAT1E: MFG OF METER DOSAGE INHALERS.

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GENERAL. ENVIRONMENTAL CONDITIONS. GARMENTS. SANITATION EQUIPMENT & MANUFACTURE. DOCUMENTTION

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PART1F: MFG OF ACTIVE PHARMACEUTICAL INGREDIENTS (BULK DRUGS)

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BUILDING AND CIVIL WORKS. UTILITIES/SERVICES. EQUIPMENT DESIGN, AND SITE LOCATION. IN-PROCESS CONTROLS. PRODUCT CONTAINERS AND CLOSURES.
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