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Metrology and Validation

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Table of Contents

Abstract Introduction Statement of the problem Hypothesis Instrument specifications, Procedure and Data Collection Discussion Conclusion Bibliography

Maxi Quality Pharmaceuticals, Inc is a worldwide manufacturing company of Transdermal Delivery Systems (TDS). The Active Product Ingredient (API) adhered to a laminate foil and coated by a plastic film creates an advanced delivery technology (Figure 1).
The active is contained in round or square patches, and the dosage is gradually released through the human skin by twenty four hours. Narrow specifications for laminated foil had been established in order to control the blending process and to guarantee the adhesion of active in the laminate. Due to the complexity of the TDS manufacturing process, there are just a few suppliers in the market constraining the availability of this raw material for Maxi Pharmaceutical, Inc. To ensure quality and product reliability the company had evaluated three different suppliers of laminated film. The application of the metrology and measurement principles on testing the thickness through Upright Gage Series 547 from Mitutoyo (Figure 2) ion for the main and ongoing supplier for this raw material.

Qualification of Raw Materials (RM) suppliers is critical on a pharmaceutical process since product quality is straightly related to the specifications attained to the materials used. FDA has established strict regulations to be accomplished by drug manufacturers to ensure quality, efficacy and safety. Companies usually deploy significant resources to assess raw material suppliers’ chain previous to launch a new product to the market. All the materials should be approved using the Company’s Change Control Procedures and /or Supplier Approval Procedures. Selection and qualification of RM suppliers are an essential component of manufacturing process development to guarantee intermediate and finished product fulfillment the specifications (APIC, 2009).
Select reliable suppliers of high-quality product are one of the four strategic objectives of pharmaceutical procurement. Prospective suppliers should be pre-qualified, and selected suppliers should be monitored through a process which considers product quality, service reliability, delivery time and financial viability. Pre- and post-qualification procedures help to eliminate substandard supplier properly managed. (WHO, 1999)
Pre-qualification is the procedure of evaluating supplier capacity and reputation before bids are solicited for specific products. This is the preferred procedure, especially for ongoing drug procurement systems. Although substantial time is required to establish an initial list of pre-qualified suppliers, once this had been done the lowest pre-qualified tendered for each product is deemed to be qualified, which expedites adjudication and contract award. Post-qualification evaluates the suppliers after bids have been received. If there are numerous offers from unknown suppliers, there may be long delays in awarding contracts, as it will be necessary to validate suppliers’ capacity to supply good-quality products. One important aspect of quality assurance is the concept of “traceability”. The supplier must be able to trace the product to the finished product manufacturer, and then latter must be able to tracking the ingredients to their producers, all in a transparent manner.
Evaluation of the consistency of the Physical Chemistry of the material contributes to the evaluation of the manufacturability of the material in next process steps (APIC, 2009). Polyester Film Laminate is classified as a non-critical raw material in manufacturing process for adhesive patches (TDS). Giga Pharmaceutical Inc. has received a business proposal from three different suppliers: Biochem Corporation Reliable Polymer Group Inc. Advanced Laminate Technologies, LLC
Suppliers were submitted through the Vendor Management across the Life Cycle process designed by the Giga to ensure quality, safety, and effectiveness (Figure 3).
Measurements, tolerance, calibration, accuracy, precision and reliability are fundamental principles of Dimensional Metrology science they are involved in all processes. The relevance of this concepts and its applications are increased on pharmaceutical process due to the fact of customer nature and the high risk of compromise their health and safety.
This term paper aims to demonstrate through an example how this metrology science terms help to qualify a raw material vendor by measuring a critical parameter on calibrate instrument.

Statement of the problem
Use of metrology and measuring principles as qualification tools to select the best laminate raw material supplier from a reduced market of vendors.

Results for thickness measurement through a calibrated Upright Gage provide consistent evidence to discern between a grade A and B raw material supplier.

Instrument specifications, Procedure and Data Collection Instrument Specifications:
Mitutoyo Upright Gage Series 547
Specifications 547-035S
Type Digital Inc/Metric
Range 0.5”
Resolution 0.00005”/0.001mm
Workpiece height 1.2”
Accuracy ±0.0001”
Measuring force 1.5N or less
Type of anvil 1.57” (DIA Steel type)
Display LCD
Scale type Absolute
Contact Point 3mm carbide flat type
Functions GO/±NG judgment. SPC data output
Next Calibration due 06/30/2011 Procedure
Principle: The average thickness of films and laminates is determined by digital thickness gauge.
Reference: Pressure Sensitive tape Council PSTC-33 (Mantelle, 2000)
Applicability: All films and laminates
Technique: Turn on the thickness gauge by pressing the ON/OFF button and zero the instrument. Raise the spindle off the base by gently pushing down on the lift lever. Ensure that the spindle is properly tightened. Insert onto the base an uncreased, unwrinkled piece of film/laminate. Lower the spindle onto the film/laminate by gently lowering the spindle using the lift lever. Record the thickness value displayed on digital readout (use the figures of magnitude stated in the material’s specification). Repeat measurement twice more on different areas of the film/laminate. (Note: 1 inch = 1000 mils). Data Collection: Sampling specialists from Maxi Pharmaceuticals coordinated with each vendor to randomly pooling one hundred fifty samples from polyester film laminate. The sample size ensures the measuring of thickness by triplicate to report the average as required by procedure G-100 (Figure 4). This grant a total of fifty samples. The data is evaluated conforming to Maxi specifications for Polyester Foil Laminate (Figure 4). In addition statistic tools support evidence for data behavior since variation from the middle is critical for manufacturing process.

Thickness is intrinsically related to laminate properties as Tensile, Wrinkles, and Adhesion. Simultaneously, manufacturing steps as coating and drying are also impacted by any variation on thickness. This is the reason why the specifications are intentionally narrowed to minimize out of specification, deviations, fluctuation and wasting time downstream in the process (Figure 4).

Figure 5 shows the histogram for results of Thickness for fifty samples from each supplier. Although that mostly all the results meet specifications (1.92-2.19 mils) supplier A achieve more consistent values, smaller dispersion from the middle and certainly a better standard deviation value comparing the others suppliers. The data is closer to a perfect Gauss’ Bell shape for A and it is widening from B to C. This could indicate that supplier A is able to satisfy Giga requirements for raw materials. The select specification limits or tolerances can delineate the range of measurement values that will accept as “close enough” to the target value, in the sense that product are within specifications (Devore & Farnun, 2005)
The statistics analysis and x ̅ bar graph illustrated on figure 6, allows weighing the data for behavior within true limits. The majority of results for supplier A fall within specification limits since only one value are out of specifications. The trend is almost even at both side of the middle. Comparing A and B results through figure 6 and 7, respectively, are observed that the most of the values for supplier B also meet specs specification. The difference lies on the amount of values being Out of Specifications. Supplier A only has one value (2%) outside of limits while supplier B has six results (12%) and two very close to the specs. This is an indication that in spite that data would be considered acceptable mathematically and good for other purposes, for this particular objective there is not strong criteria to accept this source as the first choice. This status could change after convey the technical issues of company B and the Maxi raw material needs. Probably more samples could be request to be evaluated at the future.
The outcomes for supplier C ( Figure 8) exhibit more variation and dispersion in the results than the other suppliers in concourse. A total of eight values (16%) are out of limits and three results are very close to these values. This supplier has limited possibilities at the present to become a Maxi provider. However, a partially satisfactory conditional for approval status could be assigned to this company until corrective actions are in place.
The application of the Metrology principles and methodology through the use of a calibrated Mitutoyo Upright Gage provides enough evidence to select supplier A (Biochem Cooporation) as the first choice for raw material provider. Supplier A exhibits more precise and accuracy results than supplier B and C. However, B could be considered for a mainly satisfactory status with limited approval (ongoing supplier). The narrow specifications for Polyester Film Laminate reduce the possibility to find stable suppliers. This limitation affects the increasing of TDS production at Maxi. Metrology principles and measurements helped to categorize the suppliers according to the precision and accuracy of thickness results and consequently find and alternate solutions with supplier B and C.

Figure 1. Pressure Sensitive Adhesive

Figure 2. Mitutoyo Upright Gage Series 547

Figure 3. Vendor Management Life Cycle

Figure 4. Specifications Polyester Laminate Foil

Appearance Meet requirements G-156
Core I.D 5” ± 0.032” G-232
Roll O.D ≤ 25” G-232
Web Width 22 ± 0.125” G-351
Identification: FT-IR Compares to Standard G-104
Thickness 1.91-2.19 mils G-100

Figure 5. Histogram of Thickness Supplier A, B and C

Figure 6. Data behavior for Supplier A

Figure 7. Data behavior for Supplier B

Figure 8. Data behavior for supplier B

VIII. Bibliography

APIC. (2009). Supplier Qualification and Management Guideline. Brussels: Active Pharmaceutical Ingredients Commitee (APIC).
Devore, J., & Farnun, N. (2005). Applied Statistics for Engineers and Scientists. Belmont, CA: Brooks/Cole.
Mantelle, J. (2000). Pressure Sensitive tape Council PSTC-33. Retrieved 02 26, 2011, from
WHO. (1999). Operational principles for good pharmaceutical procurement. Geneva: World Health Organization.…...

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