Procedure for preventing of product mix-ups and cross-contamination.

1.0              PREPARATION, REVIEW &APPROVAL:

           

2.0                          PURPOSE:

    To lay down the procedure for preventing of product mix-ups and cross-contamination.

3.0                          SCOPE:

This procedure is applicable to all  activities that Equipment/Machine, area, Materials  in stores, QC and production department at COMAPANY NAME.

4.0                          RESPONSIBILITY

4.1                          User department Person

4.1.1                    To follow the system necessary to prevent contamination and cross contamination.

4.2                          Concerned Department Head:

4.2.1                    To ensure SOP implemented in manufacturing facility

4.3                          Quality Assurance Head-

4.3.1                    To ensure implementation of defined system.

4.4                          Quality Head-

4.4.1                    To ensure & arrange external trainings.

4.5                          Plant Head-

4.5.1                    To ensure & arrange external trainings.

5.0                          Distribution:

5.1                          Quality Assurance

5.2                          Quality Control

5.3                          Production

5.4                          Warehouse

5.5                          Engineering

5.6                          Human resource and Administration.

6.0                          DEFINITION & ABBREVIATION(S):

6.1                          Definitions-

6.1.1                    Contamination: The undesired introduction of impurities of a chemical or microbiological            nature, or of foreign matter, into or on to a starting material or intermediate during             production, sampling, packaging or repackaging, storage or transport.

6.1.2                    Cross-Contamination: Contamination of a starting material, intermediate product or  finished product with another starting material or product during production.

6.2                          ABBREVIATION(S):

6.2.1                    QA   : Quality Assurance

6.2.2                    QC   : Quality Control  

6.2.3                    SOP : Standard Operating Procedure

6.2.4                    cGMP : Current Good manufacturing practices.

6.2.5                    GDP : Good Documentation Practices

7.0                          PROCEDURE:

7.1                          Pharmaceuticals cross contamination refers

7.2                          Cross contamination of products may be harmful & life threatening to the patient.

7.3                          Most significant cross contamination such as steroids, penicillin, Cytotoxic, Harmone, Pathogen etc which are hazardous & be prevented through facility & control defined in GMP.

7.4                          The main source of cross contaminations in drug manufacturing and other activities are Human beings, air, Equipments/Machine, Water, Raw materials their for consideration should be taken of these factors

7.5                          Facility design

7.5.1                    Health & Hygiene

7.5.2                    Sanitization practices

7.5.3                    Unwanted movements

7.5.4                    Cleaning and disinfection (Drain/Facility)

7.5.5                    Environment monitoring

7.5.6                    Environment criteria

7.6                          Material Management

7.6.1                    All raw materials, both actives and excipients shall be procured only from approved
suppliers.

7.6.2                    Stores personnel receiving the material shall follow all steps with respect to handling and
storage of raw materials and packing materials as per respective SOP.

7.6.3                    Special attention shall be provided to verify and tally the labels of containers and indented
items on receipt. On in-process material should specify the process stage.

7.6.4                    While storing the material, care shall be taken to ensure segregation of  different and stages 
like under test, approved and rejected materials

7.6.5                    Any rejected or obsolete materials shall be suitably disposed within the shortest possible
time and record shall be maintained accordingly.

7.6.6                    Dispensing of the materials shall be done only after obtaining line clearance and dedicated
cleaned scoops shall be used for dispensing.

7.6.7                    All the materials in the warehouse shall be stored over the Racks (preferably of powder coated).

7.7                          Quality control of incoming materials:

7.7.1                    QC shall follow the various steps detailed under specific sampling procedures.

7.7.2                    Special precautions shall be taken by QC to ensure that no cross contaminations occurs
 while sampling. 

7.7.3                    Dedicated or appropriately cleaned sampling equipment shall only be used for sampling.        

7.7.4                    During sampling, QC personnel shall critically verify the labels on the containers.

7.7.5                    QA Manager shall periodically carryout the review of the laboratory activities and ensure  
that the laboratory systems and procedures are sufficient to detect any mix-ups or cross-
contamination.

7.8                          Manufacturing & Packing:

7.8.1                    Production person receiving the materials issued by stores shall carefully verify the
labels on the containers and tally them with the indent.

7.8.2                    QA person shall crosscheck any weights and addition of materials in manufacturing

7.8.3                    Line clearance procedures shall be strictly followed and documented by production & QA.

7.8.4                    Effectiveness of cleaning shall be validated and records shall be maintained.

7.8.5                    Adequate in-process checks shall be in place at appropriate stages to ensure that the
manufacturing proceeds as per the plan.

7.8.6                    QA shall carry out periodic reviews of all manufacturing activities to ensure that there 
are no potentials for mix-ups or cross contamination.

7.8.7                    Care and precaution during products manufacturing, handling of finished products, in-
process manufacturing controls, labeling controls, validated cleaning procedures,
quality control procedures in addition to general GMP compliance shall be given top
priority.

7.8.8                    All the materials inside the production facility shall be stored in sealed polythene bags, in closed drums with proper identification status. For example in-process materials and finish drug products shall be stored, with clear identification status label.

7.8.9                    All the materials in the production shall be stored over the pallets (preferably of stainless steel). Packing lines shall be independent and adequately segregated. All the remains of previous packed materials (such as labels, left-over, cartons, caps etc) shall be removed before the starting of next operation.

7.8.10                All printing and overprinting shall be authorized in writing from production and quality assurance.

7.8.11                Providing appropriate airlocks, pressure differentials and air extraction.

7.8.12                Manufacturing environment condition shall be maintained at required level of temperature and humidity.

7.8.13                Proper gowning procedure shall be followed to prevent personnel contamination. Access of unauthorized persons, to control areas such as Production, Warehouse be restricted.

7.8.14                Any OOS or typical results obtained by QC during the analysis of raw materials,
intermediates and finished products shall be investigated in detail before the batch is
accepted or released.

7.8.15                QA Head or his personnel shall conduct training program from time to time regarding
mix-ups and cross contamination and impact of the same on the product quality. If
possible, live examples shall be given to highlight such situations.

7.9                          Prevention and handling of contamination with metal objects

7.9.1                    Restrict the use of metal like objects to the minimum.

7.9.2                    Wherever it is unavoidable, use the metal objects with strict control. Items like knives, scissors, pins, nuts, bolts, sieves and sampling equipments should be used with care and caution.

7.9.3                    Before start of operation and after completion of operation, check nuts and bolts, which are used for the equipments for its absence and / or loosening. Wherever nuts and bolts are loosened, the same should be tightened. In case any nuts and bolts are missing, the same should be investigated.

7.9.4                    During regular preventive maintenance or breakdown maintenance, special attention   should be given to nuts and bolts so as to prevent contamination with the same. After      preventive maintenance or breakdown maintenance, QA should give line clearance to ensure that the area / equipment is free from grease, nuts, bolts and any other maintenance tools

7.10                      Man and material movement strictly followed.

7.11                      Differential pressure is maintained and at different frequency.

7.12                      Minimum personnel should present in the area when handling/Processing of material take place.

7.13                      Unnecessary movement should be avoided.

7.14                      activities shall be followed as per defined procedures

8.0                          REFERENCE(S)& ATTACHMENT(S):

8.1                          References-

8.1.1                    In House

8.2                          Attachments

8.2.1                    Nil

9.0                          REVISION HISTORY:

9.1