01 General Information
1.1 Brief Information On The Firm
The pharma unit of M/s. Nagindas Hiralal Bhayani was constructed in year 2017-2018 to manufacture a wide range of External Liquid Preparation. The plant is located at Plot No. 2801/3, GIDC Panoli, Taluka – Ankleshwar, Dist. – Bharuch, State – Gujarat, Country –India.
1.2 Pharmaceutical Manufacturing Activities As Licensed Or Approved By The National Authorities:
1.3 Any Other Manufacturing Activities Carried Out On The Site:
The pharmaceutical manufacturing block is dedicated for the production of pharmaceutical products. External Liquid dosage forms i.e. Disinfectant, Hand Sanitizer and other etc. No non pharmaceutical activities are carried out at this pharma unit.
1.4 Name And Exact Address Of The Site Including Telephone Number, Fax And 24 Hours Telephone Numbers.
Manufacturing Site
Address: M/S Nagindas Hiralal Bhayani
Plot No. 2801/3, GIDC Panoli, Ta. Ankleshwar-394116, Dist. Bharuch, Gujarat, India
Phone: +91 7572990001
Corporate Office
Address : M/S Nagindas Hiralal Bhayani
305, Madhav Darshan, Waghawadi Road, Bhavnagar- 364002, Gujarat, India
Phone: +91 2782 431880
Fax: +91 278 2519351
Web: www.bhayanigroup.com
1.5 Types Of Actual Products Manufactured On The Site.
1.6 A Short Description Of The Site
The location and immediate environment
The site, accessible by road, railway as well as by air, is about 350 km north of Mumbai and about 100 km Vadodara. The nearest railway station is Bharuch; it is about 25 km from the site. The nearest domestic and international airport is Surat, Vadodara & Mumbai respectively. The site is located in an industrial area and is surrounded by industrial units that are of non-chemical nature. The layout of the building is unidirectional & has logical flow of Man, Material & Equipment movement according to cGMP requirement.
Description of surrounding area
North side of the pharma unit has road. South & east sides of the site are surrounded by Industrial unit, while west side having one plot place. The site (1200 m2) houses one building (regular brick cement/ modular partition) newly constructed in Year 2017-18, this is internally divided into different phases.
1.7 Use Of Outside Scientific, Analytical Or Other Technical Assistance In Relation To Manufacture And Analysis:
All activities related to manufacturing are carried out inside the factory premises. The analytical and technical support is available in-house. The quality control tests on the raw and packing material, in-process and finished goods are carried out in-house in a well-equipped Quality Control Department. The analytical and calibration assistance is taken from approved Scientific/Analytical testing laboratory for testing of few specific tests that cannot be carried out at the site.
02 Quality Management System
2.1
The manufacture of products is performed to ensure that they are fit for their intended use, comply with the quality requirements of the marketing authorization and do not place patient at risk. To achieve the quality objective, there is a system of quality assurance incorporating Good Manufacturing Practice is in place. There are different procedures in place which details the requirement
2.2
It is the NAGINDAS HIRALAL BHAYANI (PHARMA UNIT) Policy to manufacture, store and distribute quality. To achieve this, the company ensures the following:
— Maintain its equipment and building which include internal and external environment to the laid down procedure as per the requirements of cGMP.
— Adequate size, design and construction of building and equipment to provide controlled movement and storage of material as well as contamination free processing.
— Maintain the manufacturing, packing and storage area in a clean and orderly manner to eliminate possibility of mix-up, contamination and cross contamination.
— Continuously improve the GMPs in each area of operation including training of employees.
— Conducting self-inspection at regular interval so as to ensure cGMP is followed all the times and to find out the improvement requirement.
–Validating the process, equipment, system, instrument, methods and/or personnel; reviewing trend analysis to ensure continual state of validation.
— Calibration program is in place to ensure test, measurement and inspection equipments are under calibrated state and showing accurate results.
— Imparted training to all the employee to make them update in current procedure and GMPs.
2.3 Organizational Quality Policy:
“In our company we are committed to manufacture and deliver perfect product with consistent quality, efficiency and safety as per latest standards of cGMP. We are committed to promote health, hygiene, safety and environmental awareness to all personnel of the company and spread it across the society”.
Mr. Yash Bhayani
(Partner)
M/s Nagindas Hiralal Bhayani
2.4 Quality System
2.4.1. NHB Pharma unit has a well-planned quality system.
2.4.2. All the raw materials and packing materials are procured from approved vendors.
2.4.3. Materials are tested as per the current approved standard test procedures.
2.4.4. Rejected materials except printed packaging materials is segregated and returned to the Supplier or destroyed. Printed packaging material is destroyed in the premises as per SOP.
2.4.5. Only approved materials are issued to Production.
2.4.6. Reserve samples of all raw materials are maintained as per SOP.
2.4.7. The production operations are inspected by QA personnel
2.4.8. The in-process sampling is carried out by QA personnel.
2.4.9. All the in-process samples and the final products are tested as per approved and validated methods and specifications by Quality control.
2.4.10. Quality control gives the results of analysis as per specifications.
2.4.11. Batch manufacturing records are reviewed by quality assurance.
2.4.12. Quality assurance will release the approved product batches after verifying all the records and cGMP compliance.
2.4.13. Quality control department responsible for the analysis and approval of raw materials, packaging materials, Bulk and finished products.
2.4.14. Quality Assurance has the final authority in the approval or rejection of any input into the product or associated directly with the product..
2.5 Finished Product Batch Release Procedure
2.6 Management Of Suppliers:
2.6.1. Vendor of raw material are Qualified only after a satisfactory evaluation (testing) of buying samples of three lots from the vendor. An on-site inspection & Audit carried by in house expertise or any officially accredited body.
2.6.2. Vendors of primary / printed packing materials are qualified after a satisfactory evaluation (testing) of samples of one lot from the vendor..
2.7 Quality Risk Management:
2.8 Annual Product Quality Review :
2.8.1. Annual Product Quality Review (APQR) shall be prepared in the month of January of proceeding year for previous year as per established procedure
2.8.2. For products manufactured under contract manufacturing or product marketed through PL / license holder, the APQR preparation cycle shall be as per the requirements of the license holder or marketing partner/s.
2.8.3. Statistical evaluation shall be carried out to critical quality attributes of in process and finished product in which process capability index shall calculated..
2.9 TSE/BSE Free Policy:
2.9.1. As a policy we are using TSE & BSE free ingredients of all finished dosage forms.
2.9.2. TSE & BSE Free declaration shall be obtained from the manufacturer of all the API and excipients.
2.9.3. QA & Concern employee shall be periodically trained about the awareness of TSE & BSE. QA Head/Designee analyses the associated risk based on the declaration, and if requires initiates an audit on the TSE & BSE risk..
3 Personnel
3.1
Personnel who can impact safety, efficacy potency or quality of products are optimally competent based on their educational qualification, work experience, skills and trainings or combinations thereof. Organogram is attached as Annexure 4A. Name of Key Personnel and their designation, qualification & work experience is attached as Annexure 4B. List of Competent Technical staff & their FDA approvals is attached Annexure 4C.
3.2 Responsibilities
The organization has well defined responsibilities and authorities across the various functional areas for effective implementation of the Quality System.
3.3 Training
3.3.1. Training needs are identified for employees
3.3.2. Head/Designee HR & every Functional Heads are responsible for identification of the training needs.
3.3.3. On the basis of evaluation & assessment, training needs is identified. All management staff and colleagues are given cGMP training periodically by in- house and external faculty and records of trainings are maintained.
3.3.4. Training on cGMP, job specific training is given on a continuous basis with sufficient frequency to assure that colleagues have the training and necessary experience to perform the job functions in compliance with cGMP requirements.
3.3.5. GMP awareness training, job related skills training, SOP training, in – house training programme. Evaluation of the effectiveness of training or efficacy of the training is assessed by questionnaires or verbal.
3.3.6. Records of all the training programme and evaluation shall be maintained for all employees..
3.4 Health Requirements For Personnel Engaged In Production:
3.4.1. Medical examinations are carried out by an outside physician once a year for blood, Urine, vision, ECG test, Abdomen examination, respiratory system check-up, contagious diseases , ENT examination.
3.4.2. All the personnel prior to and during employment undergo medical examination.
3.4.3. Health reports are maintained for all employees who have undergone medical examination.
3.4.4. Onsite medical facilities (First-aid) are available. All the employees are routinely checked from time to time for hygiene practice.
3.4.5. Any person having an apparent illness or open lesions that may adversely affect the quality of products is not allowed to handle starting materials, packaging materials, in process materials or drug products until the condition is no longer judged to be a risk.
3.4.6. After recovery from the illness employees are asked to submit fitness certificate from the doctor to confirm the fitness..
3.5 Personnel Hygiene Requirement Including Clothing:
3.5.1. Separate suitable washing & changing areas are provided for all personnel. Every department has entry and exit procedures to be followed strictly.
3.5.2. Lint free clothing is being used for critical areas of warehouse, production to ensure protection of the products from contamination, all personnel wear clean specific uniforms appropriate to the duty they perform.
3.5.3. Clear instructions for entry / exit procedure & photographs are displayed in respective change rooms..
4 Premises & Equipment
4.1 Description Of Manufacturing Areas With Indication Of Scale:
4.2 Nature Of Construction And Finishes:
4.2.1. The building is RCC (Reinforced cement concrete) constructed with high density bricks infilling rendered with cement screen. Internal walls having thick Modular Double skin partition with 22 swg G.I. pre coated sheets, filled with puff insulation of density 40 kg/m3 ± 2 and ceiling having calcium silicate sheet.
4.2.2. Coving at ceiling to wall & wall to floor and wall to wall joints ensures ease of cleaning.
4.2.3. The drains provided in the core processing areas. Drains are SS, GMP types. & prevents back flow.
4.2.4. Doors in the Production, Stores and Microbiology section of the Quality Control area are flush panel / sandwich type duly insulated for heat loss prevention..
4.3 Brief Description Of Ventilation Systems:
4.3.1. Design Criteria: The air handling unit (AHU) system is totally separate and dedicated. Within each module, different AHUs are provided depending upon the criticality of operations having minimum 30 air changes per hour. Refer to List of AHU Annexure 5.
4.3.2. The core processing areas are designed as per class ISO 8 and Microbiology lab is designed as per class ISO 7 (at rest) to maintain temperature of NMT 25 °C and relative humidity NMT 55 % RH. The manufacturing rooms are maintained at pressure differential in relation to the adjacent passages. The Air Handling Units are designed as recirculation system, and shall have supply and return blower fan. Room air shall pass through return riser via 10 Micron pre filter to plenum Mixing chamber and Centrifugal Blower to suck and pass the filtered air. Blower drive is belt drive. Cooling coil is provided to cool the filtered air which coming from mixing chamber. Heating coil is provided to heat the air coming from the cooling coil in winter & monsoon or to maintain humidity.
4.3.3. Finally, air is filtered through 3 micron filter and HEPA filter. (EU13) HEPA filters [99.997 % at 0.3 micron] installed terminally. Insulation of polystyrene rubber with Aluminium foil is provided to prevent the chilling loss of the air and avoid the leakage of air.
4.3.4. The HVAC having efficient filtration. 10 micron HDPE filters placed on the return side of the AHU. 3 Micron HDPE filter placed in the supply chamber on the supply side of the AHU. 0.3 Micron HEPA filter placed in the Terminal Filter Box. (Reference: TRS 937 WHO, cGMP guideline) 4.3.5. HVAC Validation; every parameter has specific frequency for revalidation.
4.3.6. All filters except HEPA filters are cleaned periodically (frequency mentioned in SOPs). All the filters (primary, secondary and riser) are clean..
4.4 Brief Description Of Purified Water System:
4.4.1. The schematic layout of water system is attached as Annexure 7.
4.4.2. Purified water is used in the manufacturing & final rinsing is treated by Reverse Osmosis (RO) process.
4.4.3. Purified water system has a capacity of 1000 liter/hrs and conforming to IP/BP specification.
4.4.4. The source of water is treated GIDC water and is collected in HDPE storage tank through PVC pipe line.
4.4.5. GIDC water through feed pump introduce in dual media filter; its remove the suspended matter and turbidity corresponding to the suspended matter present in to raw water.
4.4.6. After Initial filtration water gone through anti scalant dosing, The anti Scalent dosing pump doses the anti Scalent dosing so that the Ca and Mg compound do not scale on the RO membrane.
4.4.7. After Antiscalant dosing, water passed through multigame filter of 20 µ and 5µ filter. Output from pre-treatment system pass from 5 micron filter and fed to RO membrane followed by store in buffer storage tank. The super charge resin filter is designed to polish the water by reducing the TDS in the water. After passing from Super charge resin filter water will store in final purified water storage tank.
4.4.8. The purified water is stored in 1500 L, SS 316L tank again pass through UV and then distributed to various user’s points in the manufacturing area through closed SS 316 circulating water loop.
4.4.9. The distribution loop is SS 316 construction. All fitting on the loop is of sanitary type & electroplated from the inside. The pipes are joined via orbital welding. Maximum Dead-leg in the distribution pipe work is not more than 3.0 D times the branch diameter.
4.4.10. To meet anticipated peak demands and to ensure turbulent flow around the Purified water loop, the loop has been specified for a minimum velocity in the return loop at 0.8 m/s. Valves at all user points are zero dead leg valves.
4.4.11. Pre-filters are changed as per frequency stated by manufacturer. The purified water distribution system is controlled through an integrated PLC and is continuously re-circulated at ambient temperature at the point of return from purified storage tank through all the points of usage.
The specification of water raw water:
The specification of purified water at outlet:
4.4.12. The sampling points & frequency of sampling is done as per sampling plan mentioned in standard procedure. Out of specifications data shall be listed separately with complete investigation and action taken report. Sanitization is being done by Hot water at NLT 80 0C..
4.5 Maintenance And Servicing Of The Air Handling And Water Systems
4.5.1. The engineering dept. is responsible for planned preventive maintenance for Water System, AHUs & Ventilation system and other equipment of the premises including facility. Preventive maintenance is carried out as per planned schedules mentioned into the SOP.
4.5.2. In case of breakdown of machine it is intimated to the engineering department by written Work order and repairs / rectification are carried out as per Standard Operating Procedure.
4.5.3. Maintenance routines are clearly identified that could avoid the effect on product quality.
4.5.4. Service reports of any breakdown in the department are maintained, and modification done to the equipment / instrument is explained to the users by training session..
4.6 Brief Description Of Major Production And Quality Control Laboratory Equipment:
4.6.1. All machineries, equipment being direct contact with product are constructed AISI grade SS 316 and non-contact parts are made up of SS 304 or cladded with SS 304.
4.6.2. All equipment are designed with ease of cleaning. The material of construction has been verified during qualification. Equipment design is suitable for cleaning and its use in the cleaned area.
4.6.3. All the major equipment in production like manufacturing Vessel, Air Jet Cleaning Machine Filling Machine are also as per GMP. 4.6.4. All the instrument and devices installed in the Quality control facility are designed, engineered and qualified as per the latest cGMP, cGLP and cGEP norms.
4.6.5. In Microbiology major equipment are Autoclave, Incubators etc. The list of major equipment of Production & Quality Control department including Microbiology department are enclosed as per Annexure-9 & 10 respectively.
4.6.6. Computers are used for documentation purpose and with QC / Production equipment where required.
4.6.7. All the critical manufacturing & QC equipment controlled by PLC / MMI with receipt management to prevent human errors..
4.7 Planned Preventive Maintenance And Servicing Of Equipment:
4.7.1. The engineering team is responsible for planned preventive maintenance for Water System, AHUs & Ventilation system and other equipment of the premises including facility.
4.7.2. Major Laboratory equipment /instruments shall be repaired by the equipment manufacturer or service provider. Calibration of instruments also carried out by outside party on contract basis.
4.7.3. For major equipment / machines, weekly / monthly / quarterly / yearly etc. preventive maintenance is carried out as per the plan and recorded by maintenance department as per the respective written procedures. This is being carried out as per SOPs and observations are recorded in the respective checklist.Maintenance performed is informed to the user department and is recorded in equipment usage log of production department..
4.8 Qualification, Validation And Calibration, Including The Recording Systems And Arrangements For Computerized Systems Validation:
4.8.1. Qualification of the equipment shall be performed for the new/ existing equipment and/or facility by the qualified designee (manufacturer of the equipment/facility or any designated officers of NHB Pharma unit.).
4.8.2. Company’s general policy of validation or qualification can be stated as under Validation Master Plan; for each piece of the equipment to be qualified, a qualification protocol shall be prepared. This protocol shall describe about the tests to be performed for qualification and acceptance criteria for the test.
4.8.3. The protocol shall be approved, executed and reviewed for completion by the designated individuals..
4.9 Cleaning & Sanitization:
4.9.1. The objective of Sanitation and Cleaning is to prove that the system is consistently cleaned from product residue to an acceptable level and to prevent contamination and cross-contamination.
4.9.2. Then manual cleaning activities are preferred in the plant for cleaning of all equipments, area etc. Manufacturing premises are maintained in a clean condition, free from accumulated waste, orderly and free from insects and vermin.
4.9.3. All departments have their respective cleaning and sanitation SOPs.
4.9.4. All equipments / manufacturing areas are cleaned according to the respective equipment cleaning SOP as well as cleaning validation protocol which include swabs/rinse method to evaluate the effectiveness of cleaning.
4.9.5. Cleaning methods monitored by chemical and/or microbiological methods.
4.9.6. Air Handling units are cleaned by filtered compressed air by water jet & air jet..
5 Documentation
5.1 Arrangement For The Preparation, Revision & Distribution Of Necessary Documentation:
5.1.1. There is documentation policy, which defines writing, distribution, revision, retrieval, storage and destruction of the documents. All operations are performed as per the written procedures and the records are maintained as per the procedures.
5.1.2. Concerned departmental Chemist /Designee are responsible for preparation of the documents. Each department Head/Designee is responsible for revision of documents. QA Department is responsible for distribution, retrieval and destruction of documents. The documents are controlled by QA.
5.1.3. Documents are prepared in accordance with SOP comprising standard format and instructions of how documents are to be prepared. Documents are available like product / process specifications, Specification for raw and packaging materials and test procedures, Batch Manufacturing Record and Batch Packing Record, analytical methods and QA release procedures. Any change required in master documents requires final approval by QA.
5.1.4. Every department has general SOP’s describing about activities taking place in each department and operational SOP’s describing about instruments/equipment operation validation / calibration, cleaning and maintenance.
5.1.5. Quality Assurance department SOP’s describes validation approach, training approach of on the job training, Job specific training, documentation control of process deviations; change controls and all different validation approach are described in the respective SOP, validation protocol, reconciliation of batches, reconciliation of raw materials, bulk products, major packing Components i.e. product-contact and printed materials details described in Batch Processing Records.
5.1.6. Microbiological monitoring of machines, personnel and process areas are monitored through settle plates, swabs and documented as per Standard Operating Procedure. Microbiological limit tests are conducted for water used in processing, raw material and finished drug products. Analytical test results are noted down in individual raw data book (microbiology & chemical).
5.1.7. Raw material COA’s and outside laboratory analysis test reports are maintained for cross reference. Daily records of each department are maintained as per SOP..
6 Production
6.1 Brief Description Of Production Operations:
6.1.1. Materials are procured from approved vendors as per SOP. Prior to use, materials are sampled as per SOP and analyzed by QC Department. Only approved RM are taken for dispensing.
6.1.2. The raw materials for production are dispensed batch wise and all relevant details, such as weight, batch number, analytical reference number etc. verified. Raw material dispensing of APIs are carried out in dispensing area. Before commencing production activities, area clearance is certified by QA. The manufacturing activity is commenced only after the clearance of the manufacturing and packaging line by in process Quality Assurance personnel. The documentation at production floor is carried on line. The continuous in-process checks are monitored during manufacturing in order to overcome any deviations.
6.1.3. Reconciliation is done at critical steps of manufacturing and packaging operations is carried out. In-process checks are carried out through out production & packaging operation as per BMR and BPR. As per the BMR if required, further processing is done only after the in- process results are obtained from Quality Control department / IPQA. Semi-finished products are transferred to packing on preliminary approval from Quality Assurance department. After packing, finished products are transferred to finished goods store area & despatched for sale after approval by Quality Assurance. Manufacturing Process Flow Chart are enclosed as per Annexure 8..
6.2 Arrangements For The Handling Of Starting Materials, & Finished Products Including Sampling, Quarantine, Release And Storage:
6.2.1. All the required raw materials purchase order is raised and material is procured from approved vendors.
6.2.2. Identification of suppliers lot number details are filled in Goods Receipt Note.
6.2.3. Sampling plan is based on formula n+1 and in case of active ingredient 100 % sampling is done as per procedure and analysis is carried out as per Pharmacopoeial methods and in house testing methods.
6.2.4. Labeling to the consignment is done as per status of the material as quarantine / under test, approved or rejected. Approved materials required as per production plan are issued for manufacturing and packaging.
6.2.5. During dispensing weighing is done in the presence of production and Q.A. with Stores officer.
6.2.6. Weighing tags are placed inside the primary bag of each material for identification and authenticity of respective material.
6.2.7. Control of product manufacturing:
6.2.7.1. Checks on key critical operating parameters e.g. time and speed for each mixing, is laid down in the Master Production Document, monitored during processing and recorded in the Batch.
6.2.7.2. In-process checks: All test of in-process checks are recorded in Batch record of each product.
6.2.7.3. In process checks intimation to QC for sampling, testing and analysis.
6.2.7.4. After the batch manufacturing all the records and reports of Production and QC related to respective batch are counter checked by QA. 6.2.7.5. All the documents are kept in document room for further reference.
6.2.8. Control of product Packaging :
6.2.8.1. Confirmation of identity and line clearance checks: Line clearance is verified by QA person and Production Supervisor before packaging operation. Written procedure prepared for Line clearance for packaging operations.
6.2.8.2. In-process checks: During the packaging operations as per the written procedure. The details of the checks are recorded in the Batch record.
Role of Authorized / Qualified Person(s): Batch release is the ‘one minute decision’ result of several weeks of work and is a strong commitment to the users. Batch release authorization is done by Head/Designee-Q.A. who act as of quality management system relevant to the product he is required to certify..
6.3 Arrangement For Handling Rejected Materials And Products:
Rejected material shall be kept in rejection area in lock & key and kept by affixing ‘REJECTED’ label to respective containers. On receipt of disposal / return of raw material instruction from Q.A. the material is returned to supplier. Rejected printed packaging material is destroyed in presence of Q.A. and the record of destruction is made. In case of finished drug product rejection note is issued to the production department and rejection status label is affixed on the containers, disposal is carried out accordingly.
7 Quality Control
Quality Control (QC) Department is responsible for the approval or rejection of all raw materials, all components, product containers, in-process materials and packaging materials, labeling and finished products.
All the specifications, Standard Test Procedures and General Test Procedures, Sampling Procedures for Raw Materials, Packaging Materials, In-process Materials and finished products are approved by QA Department
All the analysis and sampling is to be performed as per these written and approved procedures. Any deviation from the written and approved specifications, Standard Test Procedures, and Sampling Procedures or other laboratory control mechanisms are recorded and justified.
QC Department calibrates the Analytical Instruments and equipment at suitable intervals in accordance with an established written program containing schedules, limits of accuracy and precision, if calibration requirements are not met, investigation are carried out and appropriate action is taken.
QC Department maintains retain samples of drug substances and excipients, Reference standards, working standards, reagents and volumetric solutions required for analysis
QC Department monitors the microbial load of Purified water, potable water and environment of product process areas. Sampling of in-process materials and finished products are performed as per defined procedures and analysis of the samples is performed by QC Department. Sampling and testing are adequate to assure that batches of in-process materials or finished products meet the appropriate specification.
However, in-process material or finished products failing to meet established specifications are addressed as per SOP “out of specification”, the material / product is rejected if found necessary.
After receiving the QC analysis report for in-process materials or finished products, QA Department performs the other relevant functions like GMP compliance, BMR checking etc. prior to release of the in-process materials or finished products..
8 Distribution Complaints & Product Recall
8.1 Arrangements And Recording System For Storage And Distribution
8.1.1. Store is divided into raw material, packing material and finished goods store. The material after receipt is stored in specified environmental condition of the material. Store department is well equipped with de dusting. Received material is affixed quarantine label by stores department. Access to quarantine area is restricted.
8.1.2. There are separate ventilation systems installed for warehouse. Environmental monitoring of temperature, humidity is carried out as per the Standard Operating Procedures.
8.1.3. Material loading and unloading is carried out manually. Materials are stored on pallets.
8.1.4. Status of products is controlled by QA labeling systems indicating quarantine and approved stage. If rejection occurs material is securely isolated and kept in rejection room..
8.2 Records Of Distribution:
8.2.1. Before the batch release is done for distribution all the records are counter checked by Head QA. All documents related to batch release of manufacturing and QC analysis are kept in QA and retained till the expiry of the finished drug product + one year to handle any market complaint. All details of quantity dispatched, customer details, and date of sale are included in dispatch documents and transfer note prepared by distribution/warehouse department.
8.3 Complaints:
8.3.1. Quality Assurance is responsible for complaint handling and its investigations. Well-defined SOPs cover the complaint handling.
8.3.2. All complaints received through marketing, directly from consumers or from regulatory agency are processed by proper classification and corrective actions taken whenever required.
8.3.3. After any complaint is received, it is logged and number is assigned, after completion of investigations summary report is issued to all concerned to take corrective actions, to avoid recurrence of the complaints. All the investigations reports are reviewed by Head/Designee QA..
8.4 Product Recalls:
8.4.1. Quality Assurance is responsible for product recalls and its investigations.
8.4.2. Quality Assurance has defined SOP for handling Product recall which describes classification of defects to move with retrieval of distribution data, notification to customers, receipt / segregation/inspection of returned products, investigation / reporting of cause and reporting corrective action. Director notifies the competent authority of complaints and recall.
8.4.3. Competent Authority shall be informed after Product recall and report shall forward after complete investigation..
9 Self Inspection:
Short description of the self-inspection system: Self-inspection system shall be carried out as per schedule and prior intimation shall be given to all individual departments. Audit is carried out on points and but not be limited to housekeeping, personnel practices, operations, equipment, Documentation adherence to procedure stipulated in the individual department SOP. Self-inspection audit is carried out by Head/Designee Q.A. with individual department Head/Designee to verify whether quality systems are followed strictly during department activities.
All observations shall be discussed with the individual department Manager and Director. Head/Designee-Q.A. will prepare summary report and will be forwarded to Director for corrective actions and compliance. Director will indicate corrective actions to be taken and completion date based on the internal audit findings. Follow up audit will be carried out on the internal audit findings by Head/ designee- Q.A. as per schedule and compliance report will be prepared. Any actions not complying within the completion date will be informed to Director / Head Quality Assurance and suitable corrective actions shall be taken.