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If yes, Names: ______________________________________________________________ Addresses: ____________________________________________________________ Responsibilities/Name/Title: Production: B . Murugan, Plant Manager Quality Control: K.Balaji, Asst Manager Quality Assurance: J.Sathyanarayana, Manager - Quality If possible, please give explanations to the answers in the following questionnaire! Please fill in the questionnaire and return it to: Manager, Materials (Packing Material) Merck Limited D-116, MIDC, Thane Belapur Road, Nerul, Navi-Mumbai 400 706, India
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ANNEXURE XIX
______________________________________________________________________________
If you are exclusively a trader, who is the manufacturer and/or packager? If YES: Manufacturer: Name Packager: ________________________________ Name _______________________________ Address_______________________________ _________________________________ _______________________________ Could we have the questionnaire completed by the manufacturer and/or packager? Yes Page 2 of 17 No
Address _________________________________
ANNEXURE XIX
Please briefly describe the manufacturing process: Please enclose a flow chart (attached) Have you been approved according to ISO (e.g. 9000 series) or by other associations? Yes No N.A. If YES: Name of the associations: Already ISO 15378 System in practice and the audit will be done during Dec 2011 since the site commenced production from Jan.2011. 1.11 Date of the last audit, by: _______________________________________________________ Are you willing to provide us with copies of your current ISO certification? Latest date of certification: 1.12 1.13 Yes No N.A. ______________________________________________________ Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No No N.A. N.A. N.A. N.A. N.A. N.A. N.A.
1.10
Would you agree to on-site audit? -The location of production? -Equipment of production? -The manufacturing methods? -The technology? -The quality specification? -The test methods? -The answer to the questionnaire?
2. 2.1
Storage and handling of key raw materials incoming and final goods: Are raw materials and incoming goods stored separated from production areas? Yes No N.A.
A dedicated place assigned for each raw material and Packing material
2.2 Do you have a suitably equipped area for -Incoming goods? Yes No N.A.
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ANNEXURE XIX
_____________________________________________________________________________ Are there separated quarantine areas for materials awaiting final testing? Yes No N.A.
_______________________________________________________________________________ 2.6
2.8
2.9
2.10
2.11
ANNEXURE XIX
Batch Traceability effectively done with bar coding system. It can be traced out from finished goods to the raw material vise versa. (SOP: DPI-QA-SP008)
3. 3.1 3.1.1 Production: Buildings and facilities Do building and facilities have adequate space for the orderly placements of equipments and materials to prevent mix up? Yes No N.A.
3.1.2
All machines and equipments are in order materials are labeled and controlled by the Quality department, material movement sop in place for regular operation of materials start from Stores to the production.
Are there written cleaning instructions and records? Yes
Cleaning done before line startup and line clearance approval has been given by the Quality Department.
3.1.3 Particles of broken glass in production units are dangerous. Therefore in may companies glass policies are defined. Does a glass policy exist? Yes No N.A.
No
N.A.
In Clean room area No glassware or glass equipments are used. Light fixtures are covered with Acrylic sheet. However, glass policy is in place.
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ANNEXURE XIX
-Building sanitation? Yes No N.A. -Cleaning? Yes No N.A. -Pest control? Yes No N.A. ___________________________________________________________________________ 3.2 3.2.1 Equipment Equipment and utensils should be cleaned, stored, and where appropriate sanitized or sterilized to prevent carry-over of material which would alter the quality of the packing material beyond the official or other established specifications. Non-dedicated equipment should be cleaned between productions of different materials to prevent cross-contamination. Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents should be defined and justified if applicable.
Injection Blow Moulding for Bottle Injection Moulding - for Nozzle and Cap
No
N.A.
3.2.1.2 If no, which products are produced using the same equipment as the concerned products on Page 1? All the machines & Moulds are validated to the many products on the same machine. 3.2.2 Schedules and procedures (including assignment of responsibility) should be established for the preventive maintenance of equipment. Control, weighing, measuring, monitoring and testing equipment should be calibrated according to written procedures and an established schedule. Equipment calibration should be performed using standards traceable to certified standards, if they exist. Records of these calibrations should be maintained. Are there written -Maintenance instructions and records -Cleaning instructions and records -Operating instructions and records -Calibration instructions and records
No No No No
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ANNEXURE XIX
3.2.3.1 Do you apply the HACCP concept? Yes No N.A. ___________________________________________________________________________ 3.2.3.2 Do you define in-process controls after performing a risk analysis? Yes No N.A. ___________________________________________________________________________ ___________________________________________________________________________ 3.2.3.3 Are the production equipment/utilities qualified with regards to -Design Qualification -Installation Qualification -Operational Qualification -Performance Qualification Yes Yes Yes Yes No No No No N.A. N.A. N.A. N.A.
___________________________________________________________________________ 3.2.3.4 Are the production equipment/utilities qualified Prospectively? Retrospectively? Yes Yes No No N.A. N.A.
All equipments & machines are commissioned on Jan 2011. 3.2.4 Are your instruments (e.g. balance, measuring instruments) registered? Yes No N.A. ___________________________________________________________________________ Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. These systems should be designed and constructed to minimize risks of cross contamination and should include equipment for control of air pressure, micro organisms (if appropriate), dust, humidity and temperature.
3.2.5
3.2.5.1 Is there any air-handling system -In the manufacturing rooms? -In the packaging rooms? Yes Yes No No N.A. N.A.
(Describe briefly your air-handling system, e.g. laminar flow, Clean Room Class)
Validated Clean Room Class 8(ISO), Area 5000 Sq,Ft. having 27 HEPA filters of 0.3 micron size of 30 cycles air change per hour maintained temperature 72F RH -45-55% includes for RM preparation area. Support service room for FP preparation all under classified air handling area.
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ANNEXURE XIX
Yes No N.A. ___________________________________________________________________________ Have you installed automatic inspection equipment (e.g. opto-electronic system, camera inspection systems or barcode-readers)? Yes No N.A.
3.2.6
If yes, please answer the following questions: Have you implemented a 100% monitoring systems? Yes
No
N.A.
Do you regularly challenge the systems to verify the continued functionality, reliability and good working condition? Yes No N.A. Is a specification/description for the functionality existing? Yes No N.A.
Each work Order will have separate batch number and quantity based on the work order.
Homogeneous batch of a product that complies within the specification limits that is being ensured on hourly check on visual, once in four hours check by functional check, and final inspection as per the Test Matrix.
Is the homogeneity of the batches validated and documented?
Yes. All Products are validated on all the machines and IQ,OQ,PQ of the each product is available.
3.3.2 At which stage do you perform the full batch analysis -At each sub batch stage Yes -At the final batch size stage Yes
No No
Please describe briefly your quality control steps including test parameters as well as the frequency of the testing.
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ANNEXURE XIX
Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control. Actual yields should be compared with expected yields. Any deviation should be documented and explained. Any critical should be investigated. Are approved written procedures available for each step of -Manufacturing? -Packaging? describing all critical steps. Yes Yes No No N.A. N.A.
3.3.5
Materials to be reprocessed or reworked should be appropriately controlled to prevent unauthorized use. Does the written procedure cover Reprocessing? Reworking? Yes Yes No No N.A N.A.
No reprocess work being done in the manufacturing. All online rejection will be discarded as waste. Reworking done for the product mix up in final stage, defective products will be segregated and packed. Before the pack, Quality inspections are done, verified and approved by Quality.
3.3.6 Critical in-process controls should be stated in writing and approved by the quality units. Written procedures should describe the sampling methods for in-process materials.
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ANNEXURE XIX
3.3.6.2 Procedures should be established to reconcile the quantities of labels issued, used, returned and to evaluate discrepancies found between the number of containers labeled and the number of labels issued. All excess labels bearing batch number or other batch-related printing like order no. /consignment no. should be destroyed. 3.3.6.2.1 Do you have a system for reconciliation of labels? Yes No ___________________________________________________ No N.A. N.A.
3.3.6.3 Are process waste and unusable residues destroyed? Yes If no, do you reprocess the waste and unusable residues?
3.3.6.4 Do you release the printers copy? If yes, do you use an unchangeable reference standard? Yes No N.A. 3.3.6.5 Do you check double sheet feeling during printing? Yes No N.A.
3.3.6.6 In case of digital printing, please answer the following questions: Do you check correct transfer of the master artwork file from the customer? Yes No Do you prevent unintentional use of incorrect artwork files? Yes No Do you ensure that no obsolete artwork files can be used? Yes No Do you modify customer artwork files (e.g. EPS files)? Yes No If yes, how do you validate this procedure? Yes No Do you handle protected pdf-files? Yes No Do you use an electronic text control system? Yes No Do you use a CTP printing? Yes No N.A. N.A. N.A. N.A. N.A. N.A. N.A. N.A.
3.3.6.7 In case of production of reel-fed materials, please answer the following questions: Is the batch identity, reel number and production date recorded on the inner face of the core for each individual reel? Yes No N.A. Are splices marked using a brightly colored adhesive tape on both sides of the web? Yes No 3.3.6.8 Do you use different uses per artwork pages? N.A.
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ANNEXURE XIX
3.4.1 Packing materials should be transported in a manner that does not adversely affect their quality. 3.4.1.1 Are written procedures used to verify shipping requirements? Yes ____________________________________________________
No
N.A.
3.4.1.2 Does your contractor for transportation know and follow the appropriate transport and storage conditions? Yes No N.A. ___________________________________________________ 3.4.2 Is documentation enclosed in each shipment? Yes No N.A. ___________________________________________________________________________ Which documentation? Delivery Chalan, CoA, Invoice(if required), transport documents (excise, etc.,) Do you keep records of delivery? -By customers? Yes No -By batch numbers? Yes No ___________________________________________________ 3.4.4 How is the identity of each shipping container guaranteed? N.A. N.A.
3.4.3
A check list is recorded for each dispatch based on the reference from the work order. As per the work order the bar-coding label and shipper labels are prepared and pasted on each bag(during production)/carton. After the Quality verification the shipper label will be pasted over the carton before dispatch.
Do the parameters listed below appear on every packaging unit? -Name of the supplier Yes -Name and batch no. of the product Yes -Quantity per unit Yes ___________________________________________ Are you willing to provide other information requested by us? Yes Page 11 of 17 No N.A. No No No N.A. N.A. N.A.
3.4.5
ANNEXURE XIX
3.5
Validation Validation policy should exist and persons responsible for design, review, approval and documentation should be documented. The critical parameters/attributes should be identified and the necessary ranges should be defined for the reproducible operation.
3.5.1
Is validation performed -For manufacturing methods? Yes No N.A. - For computerized system? Yes No N.A. ___________________________________________________________________________ Does validation documentation cover a written validation protocol specifying critical process steps and acceptance criteria? Yes No N.A. ___________________________________________________________________________ Does validation documentation cover validation report summarizing the results, deviations and drawing the appropriate conclusion? Yes No N.A. _________________________________________________________________________ Personnel There should be an adequate number of personnel qualified by appropriate education, training and/or experience to perform and supervise the manufacturing operations. Training should be regularly conducted by qualified individuals and should cover at a minimum the particular operations that the employees perform and GMP. Personnel should perform good sanitation and health practice. Personnel should wear clean clothing suitable for the manufacturing activity. Additional protective apparel, such as head, face, hand, and arm coverings, should be worn, when necessary to protect the products from contamination. Smoking, eating, drinking, chewing and the storage of food should be restricted to certain designated areas separate from the manufacturing areas. Are there detailed hygiene programs established and adapted to the different needs within the factory? Yes No N.A. Page 12 of 17
3.5.2
3.5.3
3.6 3.6.1
ANNEXURE XIX
3.6.3
3.6.4
3.6.5
No
N.A.
__________________________________________________________________________ 3.6.6 Are there adequate washing and toilet facilities provided for personnel? Yes No N.A. ___________________________________________________________________________ Are these facilities separated from the manufacturing areas? Yes No N.A. ___________________________________________________________________________ Batch Documentation, Specifications The issuance, revision, superseding and withdrawal of all documents should be controlled by maintaining the revision histories. All production, control, and distribution records should be retained. Corrections to entries should be dated and signed and leave the original entry still legible. Batch production records should include complete information relating the production and control of each batch. They should be checked before issuance to ensure that it is the correct version and a legible accurate reproduction of the master production instruction. The batch production record should include a reference to the current master production being used. No N.A.
3.6.7
4 4.1
4.1.1
Are batch record properly assembled (including reprocessing)? Yes Reprocessing Not Applicable to our process. 4.1.2 Do you keep batch records? Yes
No
N.A.
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ANNEXURE XIX
3 +2 Yrs
4.2 Are deviations, incidents and rework of batches -Investigated? -Evaluated? -Reviewed? -Approved? by Quality Unit (QC/QA)? Yes Yes Yes Yes No No No No N.A. N.A. N.A. N.A.
6.1.2
available for the laboratory instruments? __________________________________________________________________________________ 6.3 Do you have quality specifications for your Raw materials? Yes No N.A. Products? Yes No N.A. _________________________________________________________________________________ 6.4 Are the tests performed according to approved written test procedures? Yes No N.A. _________________________________________________________________________________ Are written procedures available for the staff in the QC labs? (specifications, test procedures, SOPs) Yes No N.A.
6.5
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6.8
Who is responsible for the batch release? (Department and function) QA Manager /Asst. Manager (Quality) ________________________________________________________________________________
7. 7.1
Quality Assurance Who is the person in charge of the Quality Assurance? Name: J.Sathyanarayana
7.2
Is the Quality Assurance Department independent from production? Yes No N.A. _____________________________________________QA Manager reports to MD Is there a training procedure for all employees in place? Yes No N.A _________________________________________________________________________________
7.3
Please give a brief description: Induction Training programme at the time of Joining. On job training for each employees, cGMP, Personal Hygiene & Clean room entry exit procedure for Production,Stores,Quality Dept. Assessment after training in place. __________________________________________________________________________________ 7.4 __________________________________________________________________________________ Have you got a system of self-inspection/audit? Page 15 of 17
ANNEXURE XIX
We have qualified internal auditor, internal audit is done once per six month, SIP will be done by the Quality Manager once per month. The observations are discussed in the meeting with all Dept. Heads and action plan will be circulated. Each task completion will be verified and closed by the Quality Manager.
7.5 Have you got a system for supplier qualification? Yes Please give a brief description: No N.A.
Packaging material suppliers manufacturing sites are visited by the Quality department to verify and evaluate the cGMP and storage condition of the supplier with a questionnaire and subsequent approval. Majority of Raw materials are imported from France/German/Italy from a monopoly manufacturer of PE called Leyondell Bassel their materials are 21 CFR compliance.
7.6 Are all essential processes of quality assurance regulated in the form of written procedures? Yes No N.A. Frequency of supervision: once/yr (Question Not clear) __________________________________________________________________________________ 7.7 Are corrective actions taken and supervised? Yes No N.A. _________________________________________________________________________________ Do you routinely inform you customer about changes in the production process? Yes No N.A. Do you routinely inform your customer about changes in the production site? Yes No N.A.
7.8
Do you routinely inform your customer about changes in the product specification? Yes No N.A. _________________________________________________________________________________ 7.9 Have you got written procedures and records for -complaints -recalls -product failures -change Control -Out of Specification results in place ? Yes Yes Yes Yes Yes No No No No No N.A. N.A. N.A. N.A. N.A.
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ANNEXURE XIX
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