Quality Control in the Pharmaceutical Industry

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Quality Control in the Pharmaceutical Industry
quality-control

Quality Control is the main department in the pharmaceutical industry.  Quality Control (QC) is the first department in a company where products and incoming raw materials are checked and verified accordingly. QC ensures that pharmaceutical products are manufactured to a safe and consistent standard quality. QC department is responsible for quality product output manufactured in the plant.  Every Pharmaceutical company’s effort is to manufacture high-quality products to maintain their reputation and increase their profit, and to serve the best quality medicines for mankind. The role of QC is elaborated functions wise in a detailed way.

FUNCTIONS OF QUALITY CONTROL

The main task of the Quality Control in the pharmaceutical industry is to test and analysis of finished products and incoming raw materials as per pharmacopoeial standards. To ensure the quality of products complies with standards. Key functions of quality control are mentioned here:

SUPERVISION OF ANALYSIS:

Quality control has to supervise all analysis processes and in-process functions. The following parameters are to followed during supervision of analysis:

  • Spot check once a week all registers, reagents and reference standard solutions
  • Frequently observe the actual testing done by the chemist staff.
  • Review analytical reports and before singing check and confirm for :

a Completeness of all entries.

b.       Whether analysis has been done, and confirm that it has been performed as per the specified pharmacopeia or in house specifications (if specified).

c.       If not found to comply, the section head should bring to the attention of the QC in-charge / senior QC personnel so that necessary action to rectify/modify the procedure can be taken.

  • The respective section head must scrutinize for completeness all entries to date. Reagents should be store in bottles.
  • Reference standard solution, reference standards stored in the desiccator should be checked for details like name, the solvent used wherever applicable, date of preparation, date of expiry, the signature of the person preparing.
  • Regents found to be having sedimentation etc. should be destroyed and the shelf-life period should be reviewed to prevent a recurrence.
  • The respective section heads must observe in person, the work carried out by the chemist staff so that feedback on the followed, planning of work, accuracy, precision and efficiency in there can be enhanced.

CALIBRATION PROGRAM:

Calibration program is associated to establish and maintain a system for calibration for all equipment/instruments used in analysis Calibration program is very essential for any laboratory to ensure that the results found are in a prescribed range of instruments are not calibrated periodically the whole analysis may go out of acceptance criteria.

  • To ensure there written SOP for calibration of all equipment and instruments which should contain the following information.
  • i) Maintain a step by step sequential procedure for calibration. ii) Acceptance criteria.
  • Maintaining a written schedule for calibration of all equipment and instruments.
  •  To calibrate the equipment and instruments according to the scheduled program and follow the respective SOP during calibration.
  • To record and store the calibration results in the respective format provided in the SOP.
  • To stick a calibration status label on every calibrated equipment and instruments which contains the instrument/equipment name, date of calibration, the due date of calibration and sign. of person performa calibration

ANALYTICAL METHOD  VALIDATION

Analytical Method validation allows to quality control department to check the authenticity of analysis results get by a particular method of analysis applied on the product. AMV has four major goals ACCURACY, SPECIFICITY, LINEARITY & ROBUSTNESS. Every AMV should achieve these four goals to be successful. Therefore, a periodical Analytical Method validation plan should be practised in the Quality Control Department. Quality Control (QC) in the Pharmaceutical Industry implement Analytical Method validation with the following steps:-

Method validation is required for any new or amended method to ensure that it is capable of giving reproducible and reliable results.

  • What is method validation :
  • Validation of an analytical method is the process by which it is established by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical application.
  • The requirement of method validation or revalidation :
  •   New methods developed in house or adopted from the literature require complete validation.
  • The pharmacopoeial method requires partial validation.
  •  Revalidation of the proposed method is required whenever significant changes are made in the formulation, testing procedure etc.
  •  Revalidation is required whenever there is a change in the manufacturing process.
  • Procedure :

If the method is official in Pharmacopoeia, then partial validation is required and if it is in house method then all these points shall be performed.

Precision: The precision of an analytical method is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogeneous sample under normal operating circumstances. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.

Repeatability: Repeatability expresses the precision under the same operating conditions over a short interval of time.

Intermediate Precision: Intermediate Precision expresses within laboratories variations: different days, different analysts, different types of equipment etc.

Reproducibility: Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to the standardization of methodology)

ACCURACY: Accuracy is a measure of the test results obtained by a method to the true value, which is a measure of the exactness of the analytical method.

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SPECIFICITY: Specificity for any assay ensure that the single measured comes from the substances of interest and there is no interference from recipients.

LINEARITY: Linearity is a measure of the method’s ability to obtain results that are either directly or after mathematical transformation proportional to the concentration of the analyte with a given range.

ROBUSTNESS: Robustness of an analytical method parameters and provides an indication of its reliability during normal usage.

STABILITY STUDIES

The stability studies refer to the manufactured products whose quality check-ups are done to track product’s efficacy and other changes in its behaviours.

Purpose of stability testing :

1       To keep track of stability of marketed products within assign shelf life.

2       To generate data for revising shelf life (extension or reduction of shelf life).

3       To assign shelf life for new drug products.

Procedure :

  1. Stability study shall be carried out on at least three primary batches of the drug product and at least one batch every year.

2       The primary batches shall be of the same formulation and packed in the same container closure system as proposed for marketing.

3       The manufacturing process for primary batches shall be simulated that to be applied to production batches and shall provide the product of the same quality and meet the same specification as that intended for marketing.

4       Two of the three batches should be at least pilot scale batches and the third one can be smaller if justified.

5       Stability studies shall be carried out on each individual strength and container size of the formulation.

6       Stability studies shall include testing of those parameters of the product that are susceptible to change during storage and are likely to influence quality, safety and efficacy.

7       Shelf life acceptance criteria shall be derived from consideration of all available study information.

8       Two types of stability studies shall be carried out i.e. (i) Real-Time & (ii) Accelerated

Products intended for normal storage conditions

STUDYSTORAGE CONDITIONS
Long TermTemp. 250C + 20C and RH 60% + 5%
or
Temp. 300C + 20C and RH 65% + 5%
AcceleratedTemp. 400C + 20C and RH 75% + 5%

Products intended for storage in refrigerator.

STUDYSTORAGE CONDITIONS
Long TermTemp. 50C + 3
AcceleratedTemp. 250C + 20C and RH 60% + 5%

Testing Frequency :

  • In case of real-time stability studies frequency shall be normally every three months on first year and then every six months for the second year & annually thereafter & 6 months after the expiry.
  • In the case of accelerated stability studies, the testing frequency shall be minimum of three-time points including initial and final time points. Six months of stability study shall be done in this case and the time points will be 0, 1, 3, 6 months.

MAINTAINING THE RECORD OF ANALYSIS OF RAW MATERIAL, PACKAGING MATERIAL & FINISH PRODUCTS :

Quality Control (QC) in the Pharmaceutical Industry maintains the record of receipt of each delivery of each raw materials are having the following additional details:

  • Date of receipt of material
    • Name of material on the invoice/challan/ delivery note and/or containers, if the name is different from the normally accepted name.
    • The supplier’s or manufacturer’s batch or reference number.
    • The number of containers received.
    • The batch identifying number assigned on, or after, receipt.
    • The date of sampling.
      • The record of testing of each raw material also includes:
    • Date of receipt of the sample for testing.
    •    Date of testing.
    • The batch identifying number (or the laboratory reference number).
    • The results of all the tests carried out.
    • Identity and signature of the person(s) who performed the tests.
    • The signature of a second person showing that the records have been reviewed for accuracy, completeness and compliance (or non-compliance) with prescribed standards.

            The signed release or rejection (or any other status decision) by Quality control

  • Records are, where appropriate, include,
    • A statement of the weight or measure of the sample used for each test.
    • A record of all calculations performed in connection with the test, including units of measure, conversion factors and equivalence factors.
    • A complete record of data secured in the form of graphs, charts and spectra from laboratory instrumentation, properly identified to indicate the material and the lot tested.
    • A clear statement of the assigned potency where this may vary from batch to batch of material.

Packaging materials

The record of receipt of each delivery of each packaging materials are having the following additional details:

  • Date of receipt of material.
    • Supplier’s reference or batch number.
    • Any batch identifying number assigned on, or after, receipt.
    • The date of sampling.

            The record of testing of each packaging material is also include:

  • Date of receipt of the sample for testing.
    • Date of testing (or inspection)
    • The batch identifying number (or the laboratory reference number).
    • The results of testing and inspection.
    • Identity and signature of the person(s) who performed the test.
    • The signature of a second person showing that the records have been reviewed for completeness, compliance (nor non-compliance) with established standards.
    • The signed release or rejection (or any other status decision) by Quality control.

Intermediates, Bulk and Finished Products

Records of analysis should also include:

(a)        The date of manufacture.

(b)        The date of testing.

(c)        The signed release or rejection (or any other status decision) by Quality control.

Retention of Records

The period up to which laboratory records are to be retained by the manufacturer is stipulated in the Drugs and Cosmetics Act, Rules 1945.

SUMMARY:

Quality Control (QC) in the Pharmaceutical Industry is the department that performs the actual testing on raw materials, as well as final products, Packing materials, Water testing.  They execute the analysis of chemical batches or Calibration of Equipment, testing of samples, and compiling the performance data. Quality Control pays an important role in any FDA inspection. Quality Control department has to prepare maximum processing data, like Analysis Report, Calibration record, Retention of samples record, Validation of process, Validation of Instruments records. QC should be very strong in any pharmaceutical company.

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