EFFECTIVE DATE O18 NEXT REVIEW DUE 30.10.21 ‘ ‘APPROVAL General Manager Director Wine? Date: 5/11/18 Date: S118 Date: S118_ALPHAFACTS HEALTH S OLUTION Seve Document No. SMF/0i | ee ee os Effective Date orig | .. is] Review Date || 30021 Site Master File Supersedes 301115 | a INDEX s PARTICULAR ae No. L BRIEF INFORMATION ABOUT THE FIRM 16 bee 2. PERSONNEL 7-10 3, PREMISES AND EQUIPMENT HS = ol 4, DOCUMENTATION 15-20 5. | pRopuCTION 29-36 6. QUALITY CONTROL 37-38 7 DISTRIBUTION COMPLAINTS AND PRODUCT RECALL 39 8. SELF INSPECTION 40-41 For AMINORICH NUTRIRNTS BWV. authorized Signatory_ALPHAF ACTS HEALTH S OLUTIONSows Document No] [| SMF7OI ~ Site Master File [ Effective Date forriis | Review Date 30.10.21 [Supersedes 301115 1.0 BRIEF INFORMATION ABOUT THE FIRM : Alphafacts is the Research Organisation which Produce Animal Feed additives based on Plants and Vegetables. The traditional Researches are made through Team of Experts, with hhigh Quality control Parameters as per GMP and HACCP standards. The company focus on the Exclusive molecules extracted from Biological Plants, Name & address: ALPHAFACTS HEALTH SOLUTIONS BVBA Diamanstraat 8/101 2200 herentals, Belgium EMAIL:- ~ _ sales@alphafacts.eu ey. Phone +32 493826307_ALPHAF ACTS Hearru S$ OLUTION Seva SMF/O1 Site Master File 1 OL 3010.21 BO1LTS ALLNAME AND EXACT ADDRESS OF THE SITE, TELEPHONE / FAX ‘NO. AND 24 HOURS TELEPHONE NUMBERS. Name & address ALPHAFACTS HEALTH SOLUTIONS BVBA Diamanstraat 8/101 2200 herentals, Belgium 12 EMAIL: :sales@alphafacts.eu Phone +#32.493826397 ev ot oot_ALPHAFACTS Hearru § OLUTION Soave SMF/OL ‘Site Master File ] OLN18 301021 301115 Review Date Supersedes: 13 ‘TYPEOEPRODUCTS Feed Additives, ». Topicals & Fly Repellents © Hexbal Blends with Vitamins and Trace Minerals 4. Vitamins and Minerals Blends ¢. Calcium Suspension Preparations We are not manufacturing any toxic or hazardous substances_ALPHAFACTS Hearru S$ OLUTION Soave Document No. SMF/OL ‘Site Master File Effective Date OLLIE Review Date 30.1021 ‘Supersedes 30.11.15 1.4 THE QUALITY MANAGEMENT SYSTEM OF THE COMPANY. The top management of the company has decided the quality policy of the company. Our quality policy is very competent as per CGMP, QUALIFY POLICY ‘Alphafacts health solutions. isin the business of animal feed suppliment since $ years. Our relentless quest towards quality, commitments, excellence and pride is never ending and our success has continued unabated, All the products manufactured by us, are of highest quality, safe, effective and the manufacturing operation comply with the International standards ‘The in- built quality of the product is achieved by ‘Validated technology. Best resources, For AMINO_ALPHAF ACTS Hearru S OLUTION Sova Site Master File 1 O18 30.10.21 Reuew Dae 30.11.15 Effective GMP, Efficient trained personnel, Excellent product design. With all these factors our commitment to quality strengthens our conviction to provide the best to man kind. Our march towards perfection is continued with the tradition of excellence in manufacturing. ‘We strongly believe that the key factor for success is quality and we are ‘committed for the same,_ALPHAFACTS HEALTH SOLUTION Savm Site Master File 1s ‘QUALITY MANAGEMENT SYSTEM OF THE FIRM ‘Our organization always insists on quality rather than quantity. Towards this, company has instituted the following: 1. Developed exhaustive specifications from raw materials, inprocess materials to finished product. 2. Validated, approved and documented master formula which form the basis for manufacturing and packing operations. 3. Developed adequate in-process controls, 4, Descriptive Batch Manufacturing Record (B.M.R.) that mentions ‘even the smallest details related to manufacturing of product. ‘5, ~Validated, approved and documented analytical procedures. 6. The quality assurance department is completely independent of the ‘manufacturing department and reports directly tothe plant Manager. For AMINORICH NUTHIENTR &_ALPHAF ACTS HEALTH SOLUTION Seve ‘Document No ‘SMF OL Site Master File OLII8 ‘Review Date 30.10.21 ‘Supersedes 30.1115 For AMINORICHINYERIANT Ne aubeghized Signatory_ALPHAFACTS HEALTH SOLUTION Seva Document No. ‘SMF 701 ‘Site Master File Effective Date 11118 Review Date |_| 30.10.21 ‘Supersedes: 30115 2.1 QUALIFICATIONS, EXPERIENCE AND RESPONSIBILITIES OF KEY PEI EL: ‘The key personnel are the Production Manager, Quality Control Manager and the Quality Assurance Manager, These Managers have the same responsibilities for achieving the requisite product quality. Beside performing their specific tasks, they have certain joint responsibility like monitoring and control of the manufacturing environment, plant hygiene, process capability, training of personnel, approval of supplier and contract acceptors, protection of products and materials against spoilage and deterioration and retention of records ete. LIST OF ARE. Ws LIST. OF TECHNICAL HEADS SNO [NAME DESIGNATION | QUALIFICATION | STATE 1. | Mr Bart Molenaer ‘Manufacturing | Biological Enginnering | Full | 10 year ~ | ehemist time Doctor in Velerinary 2, | Dr. Khaldoun Al jaghani Product Manager | Medicine Full | 10 Year time Bachelor in Medicine 3. | Mr. Maksins Pozhydaiev | Quality Assurance Science Full | 15 year Manager time Research & Product 4. | Mr. Virender Gupta Development Masterin Pharmacy | Fulltime | 10 Year 3. [Mr Henay Lammers | Senior Management | Bachelor in Science | Full] 32 Year time Manager Quality | Doctor in Veterinary [= 6 Control Medicine Full | 24 Year v! sna a_ALPHAFACTS Heatru S OLUTION Saves ‘Document No. Site Master File Effective Date 01118 ‘Review Date 30.1021 [Supersedes | 3011.15 EMPI GAGED PRODUCTION, QUALITY CONTROL, STORAGE AND DISTRIBUTION, Numbers of employees engaged in Production Departments are: ‘General Manager I nos. Production Manager 1 nos Executives 6 nos. Supervisors 4 nos, Workers 100 nos. ‘Number of employees engaged in Q.A./Q.C. Departments: QC Manager 1 nos, QA Manager 1 nos Sr. Executives 4.108, Executives 4 nos Chemist 4 nos. Workers 60s Number of employees engaged in. Storageand_ Distribution Departments: Officers 1 nos. Jr. Officer 1 nos. ato‘ALPHAFACTS Hearru SOLurion Saves ‘Document No, ‘SMFvor_] Site Master File fective Date O11LIS Review Date. 30.10.21 ‘Supersedes 30.1115 23 BASIC IN-SERVICE TRAINING AND RECORDS: 24 ‘The company has well qualified persons to carry out entire operations effectively and efficiently. Company has induction programmes for newly recruited employees at all levels. In house training programmes are conducted for all employees at regular intervals to impart required skills in good manufacturing practices. Company invites regularly extemal training agencies to conduct training. sessions, seminars, symposium and training records are maintained accordingly, ‘HEALTH REQUIREMENTS FOR PERSONNEL ENGAGED IN PROD! I ‘At the time of appointment of an employee, they undergo medical checkup by the company’s doctor to ensure he/she is free from any contagious disease or any serious disease, All the employees are subjected to regular medical check up yearly ‘and relevant records are maintained. The employees who work in visual checking section are also subjected for eye test twice a year. Following tests are employed to assess the medical fitness of employees ~ Eye test Blood Pressure test Contagious Disease test Penicillin Sensitivity test ee!-ALPHAFACTS Heatru SOLUTION Sova ‘SME7OI Site Master File OLILIS 30.1021 Soper 3011s] 25 PERSONNEL HYGIENE / CLOTHING Personnel hygiene is most important criteria for workers working in manufacturing area. So, we orgenize periodic training for the workers to impart better standard hygiene and training documents are maintained accordingly. Facilities for personnel hygiene like washing area separate lunch box room and lockers are provided and segregated from manufacturing areas._ALPHAF ACTS Heartru SOLUTION Sova ‘SME/OL Site Master File O18 30.1021 301115_ALPHAF ACTS Heartru SOLuTION Sova ‘Document No, sae ot ‘Site Master File Effective Date, O18 Review Date 10.21 ‘Supersedes ors 3 : ‘The entire manufacturing activities at Alphafacts health solutions. are carried out in ‘ground floor. GROUND FLOOR: ‘This floor consists of Liquid section, Powder section, QA & QC Department. There is ‘separate Dispensing area for the raw material dispensing there are four Weighing Machine(P.F. Type) Coarse Powder area in which mainly the prepration of fine powder. there are 8 Pulvegizer and 4 Homogenizer for mixing. Powder section section is provided with 2 automatic filing, sealing machine & one labelling. Brief description of major equipments used in production > Powder Processing Section Pulverizer Hammer Type Pul Verizer Blade Cutting ‘Homogenizer Weighing Machine(P F Type) ‘Tray Dryer Powder Packing Section, Pouch Filling Machine Tape Roll Machine Weighing Balance Digital Poly Sealing Machine Hand Orerated Poly Seating Machine Paddle Type_ALPHAFACTS HEALTH S OLUTIONSava Site Master File LIQUID PROCESSING SECTION 1 BOILING PAN SS 2 (CENTRIFUGE 3. PRESSURE FILTER: 4 FILTER PRESS 5. = MIXERSS 6. MIXER S.S 7. DEIONIZER - SEDIMENTER SS 9 SHIFTER 10. U.Y. WATER PURIFIER. uM. WATER STORAGE TANK 12. WEIGHING BALANCE DIGITAL Fork_ALPHAF ACTS HeEearruy S OLUTIONSsvea ‘Document No. SMF/0i Site Master File Effective Date O1ILIS Review Date 30.10.21 Supersedes 30115 PROCESS FLOW [DIAGRAME ‘GOODS RAW MATERIAL DEDUSTING OF INSPECTION UNTESTED RAW STORE CONTAINERS | —* BY QC PERSSONEL| MATERIAL STORE SAMPLING OF TF REIECTED BY RAW STORE IN A ee MATERIALS, REJECTED MATERIAL os) STORE STOREINA " [IFAPPROVEDBY TESTED ac ‘MATERIAL STORE |*—] THE DISPENSING OF ISSUE TO RAW MATERIAL REQUITIONOF [| FoR [—*| PRODUCTION IN BATCH BATCH PRESENCE OF QC_ALPHAFACTS HEALTH S OLUTION Sova ‘Document No. SMFTOL ‘Site Master File Effective Date | {O11118 | Review Date 30.1021 Supersedes Gornis—] ‘Quality control department is also located at this floor. The laboratory is equipped with sophisticated instruments like HP.L.C., LR, U.V. ‘Spectrophotometers etc. Some of the functions of Quality control department are as follows A. CALIBRATION OF EQUIPMENT: All the analytical equipments and instruments are calibrated at regular frequencies by an ‘outside agent as per the written procedure and the records are maintained. Instruments log sheets are maintained indicating the usage, calibration and major servicing if any B. ANALYSIS OF RAW MATERIALS Materials are analysed as per the specification and the reports with raw data are checked and preserved. After analysis, A copy of the report is sent fo the stores departments. ‘A representative sample is kept a8 « contol sample and preserved at least 6 months after the expiry date. ‘A record is maintained forthe control samples, which indicates the quantity removed for tess fy), quantity available at‘ALPHAFACTS HEALTH S OLUTION Savea [ep OLILIs Review Date 30.1021 ‘Supersedes 30115 C. STABILITY TESTING: Stability testing of finished product is carried out as per ICH guidelines and if any change then we adopt following criteria for stability stad. (Change in formulation ~ Accelerated and long-term condition ~ 3 batches. b. Change in manufacturing process ~ Accelerated and long-term storage condition ~ 3 batches. © CHANGE in source accelerated and long term storage condition ~3 batches. 4. Change in batch size up to 10 times - one batch on long term storage condition. € Change indocation — one batch on Accelerated and long term storage condition Change in primary container ~ closure system ~ 3 batches on accelerated and long term storage condition & Change in manufacturing equipment (s) having different operating principle ~ ‘Three batch on long term storage condition.‘ALPHAFACTS Hearru SOLUTION Seven Document No. SMF7OL Site Master File Effective Date O18 Review Date 30.1021 Supersedes 30115 D, WORKING STANDARDS: ‘Working standards are prepared using a known working / reference standard and Log book indicating the usage is maintained. E, PRIMARY STANDARD: Primary standard are prepared as per the written procedure and preserved properly and records are maintained F. HANDLING OUT OF SPECIFICATION Materials, which fall out of specification, are handled as per the approved Procedure. G. MICROBIOLOGICAL ANALYSIS: Microbiological area is separated from the main working area. Entry procedures ‘are made and strictly followed. Utmost care is employed in microbiological samples, media and organisms, All the organisms used in the assays are identified at regular frequencies. ‘These are preserved in reftigerated condition between 4°C to 8°C Temperature of At the end of manufscturing, QA. reviews batch man ‘compliance and the roduct Rr te rich NUN gor AMIN_ALPHAFACTS Herarrnu SoLvurionsem ‘Document No SMFTOI ‘Site Master File Effective Date OLI18 Review Date 30.1021 Supersedes 30.11.15 3.2 CONSTRUCTION AND FINISHING: 33 ‘The walls and floors of entire factory have smooth finish. Entire flooring is made up of long size tiles with smooth finish to withstand the ‘heavy material / man movement and can be easily washable, PRODUCT CHANGE OVER: ‘Swab Tests are carried out when a new product is taken for manufacturing . We take ‘swab on tte inlet grills to ensure that itis free from previous product, AREA FOR THE HAND! HL -ARDOUS AND SENSITIZING MATERIAL: Separate restricted area is provided for storage of Isopropyl alcohol and methylene chloride in raw material store SOP for storage of IP.A. and ‘methylene chloride is prepared and displayed, In quality control department fuming cupboard is provided. The cupboards for flammable solvent are placed away from the flame. Fume cupboards are fitted with a ‘ceramic base and drainage within the hood. Switches and other controls are fitted outside the cupboards‘ALPHAF ACTS Hearrn SoLutionssva ‘Document No. SMF 701 Site Master File Effective Date O18 ‘Review Date. 30.10.21 [Supersedes 301115, 34 CEPI RECORDING SYSTEM: ‘Company has well qualified trained persons to handle all maintenance activity of the entire plant and machinery. ‘We follow the concept of total preventive maintenance. Total preventive maintenance is achieved by the following activities, A INITIAL INSTALLATION PROGRAMME OF EQUIPMENTS: This programme ensures that the machines are selected as per the requirement and installed as per manufacturer's instruction. Installation procedures are documented (Installation qualification), its operational = fequirements are checked in operational qualification, the equipment’s performance is checked in performance qualification and then equipment said to be validated for the regular production, B. SCHEDULED MAINTENANCE PROGRAMME: Maintenance schedule (preventive maintenance) is drawn for each part of ‘equipment and followed strictly. Calibrations of control panel instruments are carried out at regular frequency and the records are maintained, Filters_ALPHAFACTS Hearrn SoOLvurionsews ‘Document No ‘SMF 701 ‘Site Master File Effective Date Oris Review Date 30.1021 Supersedes 301115 35 BRIEFDI SED, CONTROL LABORATORIES (B) QUALITY CONTROL DEPARTMENT. ‘Major instruments used in Quality Control Laboratory are: S.No. : TD No. | Calibration period n UV SPECTROPHOTOMETER ni T year 2 TR 8400 (Shimadzu) H year i 3.___| HPLC (Shimadzu) 1 1 year 2,___ | ELECTRONIC BALANCE 9Dhona 200 D) 2 Weekly 3 OVEN 2 Weeki 4.__| MELETING APPARATUS 3 Weeki 5, __| BURSTING STRENGTH TESTER (MULLEN TYPE) 2 Monthy [6 | INCUBATOR afa 6 Months 7. FALLING SPHERE VISCOMETER 2 Moaiy — &_| MICROSCOPE 2 6 Months 9. pH METER Microprocessor Based 3 Daily 10. DISTILLATION APPARATUS ( SS TYPE) 10 6 Months "TLC APPRATUS MANNUAL un _ 4 Month 13. | MINTPUL VORISER 2 6 Months | 14, MOISTURE METER i 6 Months HOTPLATE 4 Monthly Is REFREEGRATOR 16 17 PAYSICAL BALANCE DIGITAL BALANCE {AUTO CLAVE (TOSHIBA) ie FURNACE_ALPHAFACTS Hearru S ouurionsava Document No SMr7or_| Site Master File Effective Date OLS Review Date 30.1021 ‘Supersedes 30.1115_ALPHAFACTS Hearrnu SoLurionssaa Document No] _[ SMF 701 Site Master File Effective Date |] 0111.18 Review Date 30.1021 Supersedes 301115 36 37 PREVENTIVE MAINTENANCE PROGRAMS FOR EQUIPMENT AND THE RECORDING SYSTEM: ‘We have prepared annual maintenance programme for preventive maintenance and work according to frequency mentioned as per schedule and records are ‘maintained accordingly. Periodic inspection and maintenance are carried out for all equipment, utilities indirectly involved in the process. Both in civil maintenance and maintenance contracts from manufactures are used. All the activities are recorded. Equipment qualification (Performance qualification): We have done the performance and operational qualification for every equipment. ‘After confirmation of parameters as pet our specification, We prepare standard ‘operating procedures and the operators are trained to achieve the maximum out put ‘with optimum energy and best performance of machine, pynoe”™‘ALPHAFACTS Heautru S oLvurion Seva ‘Document No. SMF 7 Or Site Master File ‘Eflective Date O18 Review Date 30.1021 Supersedes 30115 4.0 DOCUMENTATION: Documentation is a prime necessity in any system of quality assurance. Documentation defines the system of control and permits investigation and tracing of defective products. The system of documentation is such that the history of each product including the utilization and disposal of input materials, packing materials, and bulk and finished products may be determined, 41 ”ARATION, SION AND TATION Fi AL In Alphafacts health solutions. There is @ well comprehensive arrangement for the preparation, revision and distribution of various, necessary documents. All master documents are maintained by the Quality Assurance Department. ‘The documents are generally prepared by the concermed supervisory staff in the related department it is checked by a senior staff in the same department and for authorization it is approved by QC / QA / Production Head, Generally the documents are reviewed / revised once in two years or if required earlier. The revisions made also under go the same checking, approval and ‘authorization process. ‘The distribution and retrieval of the documents is under the control of Quality Assurance,‘Document No, Effective Date O18 Review Date 30.10.21 [Supersedes 30.1115 ‘Some of the important documents that we have are: MASTER (STANDARD) RECORDS: 1. Master Formula and methods 2. Master Packaging Instruction. 3. Testing Standard for: A. Raw Materials. B. Packing Materials, C. Intermediate Products, D. Bulk Products. E, Finished Products. 4, Cleaning and maintenance records for Building & Equipments. 5. Setting up an operational manual for manufecturing and packaging ‘equipments, 6. Calibration and validation of equipments. 7. Contro! of manufacturing equipments. 8, Training of personnel about G.M.P. and Hygiene. 9. Criteria for disposition of returned goods._ALPHAFACTS Heartu SOLUTION Spvea ‘Document No. ‘SMF 7/01 Site Master File “Efe _| foriris Review Date 30.10.21 ‘Supersedes 301115 BATCH RECORDS: Raw materials requisition. Batch manufacturing records (Log Sheet) ‘Intermediate product- test request. Intermediate product- QC. release & report. Bulk produet- test request Bulk product Q.C. release and report. Packing material requisition Printed packing materials specimens Batch packaging records 10. Finished product- test request 11. Finished produet- release and report 12 Distribution records, 13, Complaint analysis and product recall 14. Retention samples and analysis record Sop) ae gn les (pn 42 + Rejected batch / materials records + Product recalls, ‘+ Self inspection / Internal Audits._ALPHAFACTS HEAcTH S OLUTION Sava ‘Document No, 'SMF7OL ‘Site Master File Effective Date O18 Review Date 30.10.21 ‘Supersedes 3011.15‘ALPHAFACTS HEALTH SOLUTION Sava Document No] | SMF/O1 Site Master File ] Effective Date OLLIE, Review Date 30.1021 Supersedes 30.1115 ‘Status label for the equipment cleanliness is checked and new status label ‘mentioning current process is displayed. Manufacturing details are entered in BM.R. during the manufacturing operation ‘Any packing material to be destroyed, in presence of Q.A. persons, as per the written procedure and itis recorded accordingly. Equipment logbooks are maintained indicating the usage cleaning, validation or break down ete, During product change over, equipment and area are again checked and line clearance is obtained from Q.A. before starting next product Line clearance procedure for overprinting is followed strictly during product change over. We take utmost care during manufacturing of product . Before starting the production, clearance of area, Production supervisor counter checks all input materials. Batch is processed as per written insiuction in Batch Manufacturing Record (BM) Afier filling, the bottles are kept in quarantine area and tagged with “To be checked” label. After getting approval from Q.C., bottles are examined for any foreign matter. Then checked bottles are _labelled and packed. The packed bottle are transfered to finished goods store.‘ALPHAFACTS Hreacru S OLUTION Soves ‘Document No. SMF7O1 Site Master File [ Effective Date 01.11.18 Review Date 30.1021 ‘Supersedes 30.1115 5.11 INS u RTANT P Production supervisor counter checks dispensed material before it is used in the ‘manufacturing operations. Dispensed materials are processed as per the instruction given in batch manufacturing procedure. Manufacturing details are entered in B.M.R. during the manufacturing operation. At the end of every staye as mentioned in the Batch Manufacturing Record (BM), QC. is informed for sampling. Q.C. Officer samples the semifinished products as per the laid down procedure during product change over. Equipment and area are once again checked and line clearance is obtained from Q.A. before stating the production for the next product. ‘Someimportant parameters, which are monitored during manufacturing process by production persons other than regular quality assurance personnel checks, are as follows‘ALPHAFACTS HEALTH SOLUTION Sava ‘Document No. ‘SMF 01 Site Master File | Effective Date OLILIS Review Date eel Supersedes 301115 52 OF STARTIN PA AL F DI INCLUDING SAMPLING, QUARANTINE RELEASE, AND STORAGE ; MAT! ‘After receiving Raw Material, the containers are de-dusted using vacuum cleaner. Materials are counter checked for its weight as per the purchase order. Then ‘material receipt note is made and sent to Quality control department. “Materials are then transferred to quarantine area and pasted with yellow “under test” labels. After receiving material receipt (M.R.), Quality control sampling team samples the ‘material for testing. Sampling is performed at the sampling booth provided with laminar air flow unit. Proper exhaust facility is provided in the room to avoid dusting during sampling. The containers are then labelled with “container sampled “Iabel Afier the analysis approved/ rejected labels are pasted. Approved materials are transferred to Raw Material stores and tagged with “Approved” labels, Rejected Materials are tagged with “Rejected” tag and transferred into the “Rejection Area” which is under lock and key Packing, materials are stored in separate arca. The entry is restricted to authorized persons only. Production supervisor counter check the raw materials before it is used in the‘ALPHAFACTS HEALTH SOLUTION Sava ‘Document No. Effective Date } ‘SMF7OI Site Master File _ i Review Date, 30.10.21 ‘Supersedes 301115 O1ILI8 | 33 34 RC OR REWORK: Materials requiring reprocessing or reworking are either reprocessed or destroyed depending on the cause of rejection. Reprocessing should be done only after authorization, if permitted in the master formula and recorded. All destruction procedure are carried out in presence of Q.C. personnel ARRANGEMENTS FOR THE HANDLING OF REJECTED MATERIALS AND PRODUCTS All the rejected materials are labeled as “Rejected” by QC person and separated from other “Approved” or “On Test” materials during storage. Quality control department decides the disposition of such rejected materials as to destroy, reprocess or return to the vendor.‘ALPHAFACTS Hearru SOLUTION Sova ‘Document No. SMF/OL ‘Site Master File Effective Date O18 Review Date 30.10.21 ‘Supersedes 301115“ALPHAFACTS HEALTH SOLUTIONSswa SMF/OL Site Master File forint 30.10.21 Laois 60 :TEM AND PI F D PRODUCTS; Quality contro system monitors and maintains the quality of entire operation and the in- Process checks at every stage. Specifications, documentation, release procedures, sampling, destruction and analysis are key points. QC is independent ofthe production department and reports tothe top level Management. The quality control laboratory is responsible for following To prepare detailed instruction in writing for carrying out each tests and analysis. To analyze each & every consignment of raw materials and packing materials. To release or reject bulk-finished products if required. To release or reject each batch of finished product that is ready for distribution. To evaluate the quality and stability of finished products, and when necessary of Raw Material and bulk finished products. To establish shelf life and storage requirements on the basis of stability tests related to storage condition. ‘To examine returned goods as to whether such product are released after reprocessing or destroyed. To ensure that the manufacturing activities are carried out as per standard ‘operating procedure. ‘To carry out random checking of different parameters during different stages of manufacturing/ packing_ALPHAFACTS HEALTH S OLUTION Seva ‘Document No. ‘SMF/OL Site Master File Effective Date 11118 | Review Date 30.1021 [ Supersedes. 301115 82 HANDLING OF COMPLAINTS AND PRODUCT RECALLS: ‘fier receiving the complaints from marketing departments, party or through the field personnel, it is forwarded to the Q.C. manager through G.M.(Technical) in prescribed format and the same is recorded in the complaint register. QC./QA both together investigates the complaints and records the outcomes. It is intimated to the party through the marketing department. If required, control samples of the same batches are analyzed and the results are compared. Necessary actions are taken, based on the nature of complaint Remedial measures will be taken to avoid re-occurrence, If any change in formulation is required, it is initiated by O.C/QA. Manager by written instruction to formulation development department. {In case there is no need to recall the product then a suitable reply along with Investigation report sent to the client Incase product recall is requited then the distribution department is instructed to stop the further distribution and issue letter to the Stockist / Distributors to send back the product_ALPHAFACTS HEALTH SOLUTION Save SMFTOI Site Master File | O18 30.1021, sons 7, DISTRIBUTION, COMPLAINTS & PRODUCT RECALL._ALPHAFACTS HEALTH S OLUTION Sava Damasio [SME7aL_] Ste Master File [Emective Date | [01.11.18 Review Date 30.1021 [Supersedes Sous "81. RECORDING SYSTEM FOR DISTRIBUTION Afr receiving release slip from Quality Assurance department, the finished products are packed as per order copy. The finished goods store is connected to powder & liquid packing sections to avoid excessive material ‘movements. The finished producis are dispatched to various customers as per the ‘order along with invoice original copy, transporter copy, accounts copy, excise copy. Records of distribution for a batch is maintained in order to facilitate prompt and complete recall © of-=—the. = batch © if necessary-ALPHAFACTS __ HEALTH SOLUTION Seven _ Site Master File‘ALPHAFACTS HEALTH S OLUTION Ssvea ‘Self-Inspection is conducted in order to monitor the implementation and ‘compliance status of GMP principles and quality policy of organization. 1. To determine whether quality activities and results comply with written quality plans, procedure and programs. 2. To evaluate the performance of the established quality system. To verify the effectiveness of the corrective actions. 4, To propose necessary corrective measures. If required This would help us in regular maintenance of the building premises, equipment records ‘and continuous training of the personnel. The persons responsible for self inspections are 1. Manager- Quality Assurance, 2. Manager- Production 3. Manager- Maintenance, 4. Manager- Quality Control In case any of the above mentioned person are not available for self- inspection, They shall depute another person from their department. Self-andit system is followed by above mentioned team at a fixed time interval. All spartments are audited and documented. The self-audit team ensures that ‘the SOPs are 8 followed by all. They sive training to the staff accordingly and sugapet hy “U7 ducts, sanitation ete. and sidered(“ALPHAFACTS = = HEALTH S OLUTION Savon ‘Document No. ‘SMF /0i ‘Site Master File Effective Date 11118 Review Date 30.1021 Ss 30.1115 _ . FOR nite) “GOING THROUGH THE SITE MASTER FILE